Model Number 37603 |
Device Problems
Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913); Impedance Problem (2950)
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Patient Problems
Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/25/2012 |
Event Type
Injury
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Manufacturer Narrative
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Section d information references the main component of the system and other applicable components are: product id 37603 lot# serial# (b)(4) implanted: (b)(6) 2012 explanted: product type implantable neurostimulator product id 3387s-40 lot# va17evv serial# implanted: (b)(6) 2016 explanted: product type lead product id 3387s-40 lot# v741339 serial# implanted: (b)(6) 2012 explanted: (b)(6) 2016 product type lead product id 3387s-40 lot# v741339 serial# implanted: (b)(6) 2012 explanted: product type lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A manufacturer representative (rep) reported a lead issue.It was stated that a new lead was placed and the implantable neurostimulator (ins) was moved due to displacement.The revision occurred in (b)(6) 2016 and the lead was moved because the patient was getting side effects from stimulation since it was initially implanted in (b)(6) 2012.The patient's indication for implant is dystonia, intractable spasticity, other spasticity and movement disorders.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Additional information was received.It was reported that interrogation was performed.It was reported that an impedance issue was noticed after implantation.It was noted that lead was not used in programming.It was unknown what the cause of the issue was.It was also noted that the issues were not resolved.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the healthcare professional.It was reported that the cause of the impedance issues was determined; however, no cause was reported.No troubleshooting was reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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