Model Number 6935M62 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2024 |
Event Type
malfunction
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Event Description
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It was reported that the right ventricular (rv) lead was returned to the manufacturer, analyzed, and subsequently tested out-of-specification.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the proximal portion of the lead was returned, analyzed.Analysis indicated the bonding/backfill was insufficient.There was blood on the proximal conductor of the lead and it was not obstructed.There was blood on a defibrillation conductor and it was not obstructed.There was blood on the distal conductor of the lead and it was obstructed.There was blood on the distal connector.The analyst noted there was blood ingress in lead from the proximal end.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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It was further reported the patient had previously passed away prior to the return of the lead to the manufacturer.Additional information related to the cause of death was requested and is not available.
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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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