Model Number 302-20 |
Device Problem
High impedance (1291)
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Patient Problem
Seizures (2063)
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Event Date 10/25/2019 |
Event Type
malfunction
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Event Description
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It was reported that a patient's generator was interrogated and high impedance was detected.The patient also had a seizure after previously being well controlled.The patient was referred for surgery.No surgical intervention has occurred to date.No additional information has been received to date.
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Event Description
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Suspect lead product analysis was completed and approved.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.Since a portion of the lead assembly was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Explanted generator product analysis was completed and approved as well.An electrical evaluation showed that the device performed according to functional specifications.The battery showed an ifi=no condition.No additional information has been received to date.
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Event Description
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It was reported that the patient had a full revision.It was reported that during the revision, a new lead was implanted and tested with the previous generator.The previous generator tested with high impedance at this point, even after system diagnostics were performed and pin reinsertion was attempted.Once a new generator was connected to the new lead, the impedance was within normal limits.The generator and a piece of the lead were received for product analysis.Product analysis of the generator and lead has not been completed and approved to date.The high impedance that occurred when the previous generator was connected to the new lead is captured in mfr report #1644487-2020-00155.The high impedance that occurred before the lead revision is captured in this report.No additional relevant information has been received to date.
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Manufacturer Narrative
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Device evaluated by mfr?, data correction: selection of "yes" was inadvertently omitted in supplemental report #2.
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Search Alerts/Recalls
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