Model Number G124 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2023 |
Event Type
malfunction
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Event Description
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It was reported that, during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d).This device exhibited setscrew issues, the right ventricular lead was attempted to be inserted, however, it would continuously detach after engaging with the setscrew.There was no visible lead damage, therefore, it was decided to replace this device with a new one.The implant procedure was successfully completed with the new device.This device is expected to be returned for evaluation.No further 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.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.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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Event Description
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It was reported that, during the implant procedure of this cardiac resynchronization therapy defibrillator (crt-d).This device exhibited setscrew issues, the right ventricular lead was attempted to be inserted, however, it would continuously detach after engaging with the setscrew.There was no visible lead damage, therefore, it was decided to replace this device with a new one.The implant procedure was successfully completed with the new device.This device is expected to be returned for evaluation.No further adverse patient effects were reported.
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Search Alerts/Recalls
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