Model Number 37604 |
Device Problems
Device Operates Differently Than Expected (2913); Impedance Problem (2950)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 09/28/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
Date of event was reported as: impedance issues arose a month after implant (implant date: (b)(6) 2017).Information references the main component of the system and other applicable components are: product id 3708760, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type extension.Product id 3708760, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type extension.
|
|
Event Description
|
Information was received from healthcare professional (hcp) via the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins) for parkinson¿s dual and movement disorders.It was reported that impedance issues arose a month after implant of device.The clinician programmer detected out of range issues with the device system during follow up.Surgery was then scheduled to examine the source of the problems.As an external factor/environmental factor that may have led to the issue, it was surmised that the ¿glue¿ used with extensions for research may have compromised the functionality of the extension.An external neurostimulator (ens) with a twistlock and a clinician programmer confirmed the lead impedances were ok.The clinician programmer was used to test the full device system intraoperatively.It was determined the extensions needed to be replaced.It was reported that the surgeon replaced both extensions which resolved the impedance issues.The issue was reported as resolved at the time of report.There were no further complications reported or anticipated.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
No additional information was received.
|
|
Manufacturer Narrative
|
Analysis of the extensions (serial nos.(b)(4)) found the proximal ends of the extensions were not completely seated in the ins connector ports.Conclusion codes updated.Result codes updated.If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
(b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|