Model Number 3058 |
Device Problems
Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)
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Patient Problems
Pain (1994); Electric Shock (2554)
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Event Date 03/15/2024 |
Event Type
Injury
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Event Description
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Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that electric shocks in the pacemaker pocket.There is pain and the ins is out of service.Patient has pain on the pacemaker bag despite switching off the ins.
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Manufacturer Narrative
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G2: country germany 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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Manufacturer Narrative
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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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Additional information was received.The manufacturer representative (rep) reported explanted implant.
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Event Description
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Additional information was received.The manufacturer representative (rep) reported the most likely caused was trauma, as patient fell on their ins.The symptoms have vanished completely after explantation.Patient's indication for use was fecal incontinence and urgency.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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