Model Number 5076-52 |
Device Problems
Mechanical Problem (1384); Over-Sensing (1438); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
Injury
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Event Description
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It was reported that approximately six weeks after implant, the right ventricular (rv) lead displayed high and variable thresholds and triggered a lead integrity alert (lia) due to sensing integrity counter (sic) and high rate non-sustained episodes.Additionally, the rv lead displayed high pacing impedance, pacing impedance spikes, and a drop in r waves. the right atrial (ra) lead triggered an alert for high thresholds and displayed far field r-wave (ffrw) oversensing.A connection issue between the leads and implantable cardioverter defibrillator (icd) from a possible grommet or setscrew issue was suspected. the system was explanted and replaced with a single chamber system.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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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 an x-ray confirmed that the rv and ra leads had become dislodged prior to explant.
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Manufacturer Narrative
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Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated atrial oversensing due to far-field r-waves.Analysis of the device memory indicated atrial pacing capture threshold was elevated.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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