Model Number 3501 |
Device Problems
Failure to Read Input Signal (1581); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/15/2023 |
Event Type
malfunction
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Event Description
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It was reported the physician saw a lower signal amplitude via the latitude remote patient monitoring system, and a follow-up and x-ray of this subcutaneous implantable cardioverter defibrillator (s-icd) system were performed.The follow-up confirmed a morphology change and lower amplitude.Impedance was in range and stable.The x-ray suggested both an electrode and device dislodgement.The physician noted the patient had a liquid secretion and accumulation in the pocket and lead zone after implant, although there was no confirmation of infection.The physician suspected this caused the stitches to loosen.The device was reprogrammed to secondary vector, and a system revision will be performed in the coming days.No adverse patient effects were reported.This s-icd system remains in service.
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Event Description
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It was reported the physician saw a lower signal amplitude via the latitude remote patient monitoring system, and a follow-up and x-ray of this subcutaneous implantable cardioverter defibrillator (s-icd) system were performed.The follow-up confirmed a morphology change and lower amplitude.Impedance was in range and stable.The x-ray suggested both an electrode and device dislodgement.The physician noted the patient had a liquid secretion and accumulation in the pocket and lead zone after implant, although there was no confirmation of infection.The physician suspected this caused the stitches to loosen.The device was reprogrammed to secondary vector, and a system revision will be performed in the coming days.No adverse patient effects were reported.This s-icd system remains in service.To date, no additional information has been received.Should additional follow-up information be provided in the future, an updated report will be issued.
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Manufacturer Narrative
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To date, boston scientific has not received confirmation of whether or not a system revision has been performed, and neither the s-icd nor the electrode have been returned for technical analysis.Without a returned product it is not possible to definitively confirm how it may have contributed to the complaint incident.If pertinent information is provided in the future, an updated report will be submitted.
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Search Alerts/Recalls
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