Model Number 6947M62 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id: 419488 lead & 507652, lead implanted: (b)(6) 2012.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 reported that lead warnings triggered on the right ventricular (rv) lead due to undefined high rv defibrillator coil and superior vena cava (svc) coil impedances.A lead fracture was confirmed.During the subsequent lead revision procedure, the left ventricular (lv) lead had dislodged.The rv and lv leads were explanted and replaced.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 partial lead was returned in segments and analyzed.The right ventricular defibrillation coil conductor was fractured in-vivo at the crimp of the cross-grove.The exposed right ventricular defibrillation coil was covered in body tissue/fibrotic growth.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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