Model Number 5076-52 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/13/2024 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id 5076-45 (serial: (b)(6)); product type: 0270-lead-lv-pace; implant date (b)(6) 2012; explant date (b)(6) 2024 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 the right ventricular (rv) lead had fractured.The rv lead was 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 full lead was returned in segments, analyzed, and no anomalies were found.The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth.Visual analysis of the lead indicated apparent explant damage.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 that the pacing lead was returned, analyzed and tested out-of-specification.
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Search Alerts/Recalls
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