Model Number G154 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2023 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited loss of capture on the left ventricular (lv) lead.Additionally, the right ventricular (rv) lead exhibited high pacing impedance measurements and high threshold with intermittent capture.Subsequently, a revision procedure was performed.During the explant of the device, when the device was being removed from the pocket it was noted the lv lead was fractured at the header.The device was explanted and replaced, and the lv and rv lead were surgically abandoned.The device and the broken lead will be sent back for device analysis.No additional adverse patient effects were reported.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system had exhibited loss of capture on the left ventricular (lv) lead.Additionally, the right ventricular (rv) lead exhibited high pacing impedance measurements and high threshold with intermittent capture.Subsequently, a revision procedure was performed.During the explant of the device, when the device was being removed from the pocket it was noted the lv lead was fractured at the header.The device was explanted and replaced, and the lv and rv lead were surgically abandoned.The device and the broken lead will be sent back for device analysis.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
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Search Alerts/Recalls
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