Sudden failure of dual channel pulse generators.
Identifieur interne : 001110 ( Ncbi/Merge ); précédent : 001109; suivant : 001111Sudden failure of dual channel pulse generators.
Auteurs : François Alesch [Autriche]Source :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2005.
English descriptors
- KwdEn :
- MESH :
- instrumentation : Deep Brain Stimulation.
- methods : Deep Brain Stimulation.
- radiation effects : Subthalamic Nucleus.
- therapy : Parkinson Disease.
- Electric Power Supplies, Electrodes, Implanted, Equipment Design, Equipment Failure, Equipment Failure Analysis, Follow-Up Studies, Humans.
Abstract
We report a series of four sudden hardware failures in dual channel pulse generators implanted for chronic stimulation of the subthalamic nucleus in the treatment of Parkinson's disease. In all cases, a sudden and severe deterioration of the patient's neurological condition occurred with symptoms similar to those present before surgery. In all cases, destructive analysis of the generator revealed a fracture of the wire bonds connecting the battery to the hybrid (electronic) part of the pulse generator. This fracture led to repeated Power On Resets, bringing the parameter settings back to default (factory settings). As a cause, we propose that relative movements between the hybrid and the battery led to low cycle fatigue fractures due to insufficient stiffness of the device. That three of four failures occurred when the implant was in the infracostal region makes it likely that the fractures depend on the mechanical stress applied to the device. The efficacy of the therapy resumed immediately after device replacement. As a corrective measure, the manufacturer has added epoxy between both components, increasing significantly the stiffness of the device.
DOI: 10.1002/mds.20354
PubMed: 15580627
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pubmed:15580627Le document en format XML
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<author><name sortKey="Alesch, Francois" sort="Alesch, Francois" uniqKey="Alesch F" first="François" last="Alesch">François Alesch</name>
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<placeName><settlement type="city">Vienne (Autriche)</settlement>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Deep Brain Stimulation (instrumentation)</term>
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<term>Electric Power Supplies</term>
<term>Electrodes, Implanted</term>
<term>Equipment Design</term>
<term>Equipment Failure</term>
<term>Equipment Failure Analysis</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Parkinson Disease (therapy)</term>
<term>Subthalamic Nucleus (radiation effects)</term>
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<keywords scheme="MESH" qualifier="instrumentation" xml:lang="en"><term>Deep Brain Stimulation</term>
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<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Deep Brain Stimulation</term>
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<keywords scheme="MESH" qualifier="radiation effects" xml:lang="en"><term>Subthalamic Nucleus</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Electric Power Supplies</term>
<term>Electrodes, Implanted</term>
<term>Equipment Design</term>
<term>Equipment Failure</term>
<term>Equipment Failure Analysis</term>
<term>Follow-Up Studies</term>
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<front><div type="abstract" xml:lang="en">We report a series of four sudden hardware failures in dual channel pulse generators implanted for chronic stimulation of the subthalamic nucleus in the treatment of Parkinson's disease. In all cases, a sudden and severe deterioration of the patient's neurological condition occurred with symptoms similar to those present before surgery. In all cases, destructive analysis of the generator revealed a fracture of the wire bonds connecting the battery to the hybrid (electronic) part of the pulse generator. This fracture led to repeated Power On Resets, bringing the parameter settings back to default (factory settings). As a cause, we propose that relative movements between the hybrid and the battery led to low cycle fatigue fractures due to insufficient stiffness of the device. That three of four failures occurred when the implant was in the infracostal region makes it likely that the fractures depend on the mechanical stress applied to the device. The efficacy of the therapy resumed immediately after device replacement. As a corrective measure, the manufacturer has added epoxy between both components, increasing significantly the stiffness of the device.</div>
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<Day>24</Day>
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<DateCompleted><Year>2005</Year>
<Month>05</Month>
<Day>09</Day>
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<DateRevised><Year>2006</Year>
<Month>11</Month>
<Day>15</Day>
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<Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN>
<JournalIssue CitedMedium="Print"><Volume>20</Volume>
<Issue>1</Issue>
<PubDate><Year>2005</Year>
<Month>Jan</Month>
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<Title>Movement disorders : official journal of the Movement Disorder Society</Title>
<ISOAbbreviation>Mov. Disord.</ISOAbbreviation>
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<Pagination><MedlinePgn>64-6; discussion 66</MedlinePgn>
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<Abstract><AbstractText>We report a series of four sudden hardware failures in dual channel pulse generators implanted for chronic stimulation of the subthalamic nucleus in the treatment of Parkinson's disease. In all cases, a sudden and severe deterioration of the patient's neurological condition occurred with symptoms similar to those present before surgery. In all cases, destructive analysis of the generator revealed a fracture of the wire bonds connecting the battery to the hybrid (electronic) part of the pulse generator. This fracture led to repeated Power On Resets, bringing the parameter settings back to default (factory settings). As a cause, we propose that relative movements between the hybrid and the battery led to low cycle fatigue fractures due to insufficient stiffness of the device. That three of four failures occurred when the implant was in the infracostal region makes it likely that the fractures depend on the mechanical stress applied to the device. The efficacy of the therapy resumed immediately after device replacement. As a corrective measure, the manufacturer has added epoxy between both components, increasing significantly the stiffness of the device.</AbstractText>
<CopyrightInformation>(c) 2004 Movement Disorder Society.</CopyrightInformation>
</Abstract>
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<ForeName>François</ForeName>
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<AffiliationInfo><Affiliation>Neurosurgical Department, Medical University of Vienna, Vienna, Austria. francois.alesch@meduniwien.ac.at</Affiliation>
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<MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D046690">Deep Brain Stimulation</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="Y" UI="D011211">Electric Power Supplies</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D004567">Electrodes, Implanted</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D004867">Equipment Design</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="Y" UI="D004868">Equipment Failure</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D019544">Equipment Failure Analysis</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D005500">Follow-Up Studies</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D010300">Parkinson Disease</DescriptorName>
<QualifierName MajorTopicYN="Y" UI="Q000628">therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D020531">Subthalamic Nucleus</DescriptorName>
<QualifierName MajorTopicYN="N" UI="Q000528">radiation effects</QualifierName>
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<affiliations><list><country><li>Autriche</li>
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