Model Number 3708660 |
Device Problems
Break (1069); Low impedance (2285)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/04/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and deep brain stimulation (dbs) therapy indications.It was reported that during the stage 2 surgery impedance tests were ran intra-op with freshly implanted full dbs system, contacts in front channel (left) within normal limits, contact 9 & 10 in posterior channel (right) impedances "low".Diagnostics/troubleshooting included doctor loosening the set screw, impedances were still "low".Tried the same set of events again, impedances were "low".Inserted left lead into back channel, impedances 8-11 within normal limits.Disconnected right lead from extension of skull, tested lead with twistlock = impedances normal.Doctor removed both extensions from body.Re-tunneled with same left extension and new right extension.Impedances were all within normal limits.The issue is reported to be resolved at the time of event.The extension is expected to be returned for analysis.No symptoms were reported.No further complications were reported or anticipated with this event.
|
|
Manufacturer Narrative
|
Analysis of the extension (serial no.(b)(4)) found no anomaly.(b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
Additional review identified this event should be reported for serious injury.Correct product code to mru as the patient is implanted for dystonia.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Additional information was received.Troubleshooting also included removing right extension from ins, cleaning it off and reinserting, but contacts 9 and 10 were still low.The etiology was considered related to device/therapy and not related to procedure.The event was resolved without sequelae on the day of surgery.The cause of low impedances was not determined.It was reported the event resulted in medical/surgical intervention to prevent life threatening illness/injury/permanent impairment to a body structure/function.
|
|
Search Alerts/Recalls
|