MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number 37612 |
Device Problems
Migration or Expulsion of Device (1395); Unstable (1667)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2023 |
Event Type
Injury
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Manufacturer Narrative
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Section d references the main component of the system.Other medical products in use during the event include: brand name ; product id neu_burrholecap (serial: unknown); product type: 0001-accessory; implant date ; explant date brand name lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; implant date ; explant date.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Mdt rep stated that per healthcare provider, there was a "burr hole failure", more specifically, the cover failed.Rep stated this all occurred with another mdt rep who is no longer with mdt, so they have limited information.The day after the sensight leads were placed, it was discovered on a post-op ct that the lead had migrated.The patient was taken back to surgery.Within days, the other lead migrated and again the patient was taken back to surgery.Rep didn't know what was done at either surgery to resolve the lead migrations and "burr hole failure". the troubleshooting steps that were taken on the call resolved the issue.
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Search Alerts/Recalls
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