Model Number 5076-45 |
Device Problems
Failure to Capture (1081); Electrical /Electronic Property Problem (1198); Fracture (1260); High impedance (1291); Capturing Problem (2891); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: 407452 lead implanted on 22-may-2005.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 (b)(6) 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 exhibited suspected over-sensing during a procedure.Electromagnetic interference was suspected.The right atrial (ra) lead exhibited lead warning.The implantable pulse generator (ipg) system remains in use.No patient complications have been reported as a result of this event.
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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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It was further reported that the ra lead exhibited loss of capture, no pacing, high impedance, polarity switch with potential lead fracture.The ra lead was inactivated.
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Search Alerts/Recalls
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