Model Number 3501 |
Device Problems
Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
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Patient Problem
Shock from Patient Lead(s) (3162)
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Event Date 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that one day post implant, this electrode and subcutaneous implantable cardioverter defibrillator (s-icd) experienced a lack of sensing, low r wave amplitude and a flatline on the subcutaneous electrogram (egm) strip, resulting in untreated episodes and an inappropriate shock.The smart pass feature of the s-icd was disabled.The field representative noted that there was no saline flush during the procedure.Technical services reviewed and noted this was likely air bubbles or a possible insertion issue and suggested x rays to confirm insertion.Additional information is being requested from the field.This electrode remains in service.No adverse patient effects were reported.
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Event Description
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It was reported that one day post implant, this electrode and subcutaneous implantable cardioverter defibrillator (s-icd) experienced a lack of sensing, low r wave amplitude and a flatline on the subcutaneous electrogram (egm) strip, resulting in untreated episodes and an inappropriate shock.The smart pass feature of the s-icd was disabled.The field representative noted that there was no saline flush during the procedure.Technical services reviewed and noted this was likely air bubbles or a possible insertion issue and suggested x rays to confirm insertion.Additional information is being requested from the field.This electrode remains in service.No adverse patient effects were reported.Additional information was received that it was unknown if x rays were performed.Device testing showed no further sensing issues.No further action or intervention is planned to my knowledge and no further patient complications.
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Search Alerts/Recalls
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