BEUDAMED
    FDA Adverse Event Death Summary report: N

    GALLANT HF

    MDR report key: 21670748 · Received March 21, 2025

    Report

    Report Number
    2017865-2025-28093
    Event Type
    Death
    Date Received
    March 21, 2025
    Date of Event
    March 2, 2025
    Report Date
    July 13, 2025
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05415067032010
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROVIDED SESSION RECORDS WERE REVIEWED BY TECHNICAL SERVICES (TS) AND IT WAS DETERMINED THAT THE DEVICE WAS UNDER-SENSING R-WAVES. VENTRICULAR FIBRILLATION THERAPY ASSISTANCE (VFTA) WAS NOT TRIGGERED DUE TO THE DEVICE SENSING IN AND OUT OF THE EPISODE. THE DEVICE PERFORMED PER PROGRAMMED SETTINGS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT VENTRICULAR UNDER SENSING WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT'S CLINIC REVIEWED TRANSMISSIONS DATED (B)(6) 2025 SENT AT 2.00 AM. EPISODES ON (B)(6) 2025 FROM 11.36 PM TO 11.45 PM DISPLAYED NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) AND NON-SUSTAINED RIGHT VENTRICULAR OVERSENSING (NSRVO). EPISODES ON (B)(6) 2025 AT 2 AM SHOWED NO CARDIAC ACTIVITY. THE PATIENT'S FAMILY NOTIFIED THE CLINIC ON (B)(6) 2025 OF THE PATIENT'S DEATH. A REVIEW OF THE ELECTROCARDIOGRAMS (EGMS) BY TECHNICAL SERVICES REVEALED UNDER SENSING DUE TO THE DIFFERING AMPLITUDE OF R WAVES AND THE PROGRAMMED SETTINGS. DUE TO THIS UNDER SENSING RESULTING FROM VARYING R WAVE AMPLITUDES THE DEVICE KEPT GOING IN AND OUT OF THE EPISODE. THE DEVICE WAS PROGRAMMED WITH VFTA (VENTRICULAR FIBRILLATION THERAPY ASSISTANCE) ON, BUT IT DID NOT SENSE TWO CONSECUTIVE DISCRIMINATION SIGNALS. THERE WERE ALSO INSTANCES WHERE THE DEVICE BIVENTRICULAR PACED INTO REFRACTORY TISSUE WHICH APPEARED AS NON-CAPTURE BUT WAS DUE TO UNDER SENSING BEFORE BIVENTRICULAR PACING. THE PHYSICIAN BELIEVED THE PATIENT'S OTHER PREEXISTING MEDICAL CONDITIONS CONTRIBUTED TO HIS DEATH. THE PATIENT HAD CHRONIC KIDNEY FAILURE AND REFUSED DIALYSIS TREATMENT. INFORMATION RECEIVED NOTES THE DEATH OCCURRED AT THE PATIENT'S RESIDENCE AT NIGHT, THE PATIENT WAS NOTED TO PASS PEACEFULLY. THE PHYSICIAN BELIEVED THE SYSTEM WAS FUNCTIONING AS PROGRAMMED. THE PHYSICIAN DID NOT BELIEVE THERE WAS ANY MALFUNCTION OF ABBOTT PRODUCTS PRIOR TO, DURING, OR AFTER THE EVENT. THE SYSTEM REMAINED IMPLANTED AND WAS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139435 GALLANT HF NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDHFA500Q S000087445 05415067032010

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death DURATA TACHY MRI| QUARTET| TENDRIL STS