Model Number 5076-58 |
Device Problems
High impedance (1291); Over-Sensing (1438); Under-Sensing (1661); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2024 |
Event Type
Injury
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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 reported that five days post implant the right ventricular (rv) lead exhibited a lead warning for high undefined impedance.The right atrial (ra) lead exhibited oversensing on stored electrograms (egm).Both leads were repositioned and remain 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 that the ra and rv leads were repositioned because they both dislodged and pulled back into the superior vena cava (svc).The leads exhibited intermittent undersensing and oversensing as a result of the dislodgement.It was noted that the high rv impedance occurred during the repositioning procedure.
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Search Alerts/Recalls
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