Model Number A219 |
Device Problems
Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Data Problem (3196)
|
Patient Problem
Shock from Patient Lead(s) (3162)
|
Event Date 02/27/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that one day post implant, this 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 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 s-icd remains in service.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
If pertinent information is provided in the future, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that one day post implant, this 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 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 s-icd 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.
|
|
Manufacturer Narrative
|
If pertinent information is provided in the future, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|