BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 10204533 · Received June 28, 2020

    Report

    Report Number
    2938836-2020-07120
    Event Type
    Malfunction
    Date Received
    June 28, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 13, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    FURTHER INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. PROVOCATIVE TESTING WAS COMPLETED AND NO OVERSENSING WAS OBSERVED. THE PATIENT WAS STABLE.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS.  BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING FOLLOW-UP, NON-SUSTAINED OVERSENSING (NSO) WAS OBSERVED. ABBOTT TECHNICAL SUPPORT REVIEWED THE EPISODES AND FOUND MOST NSO EPISODES WERE DUE TO COMPETITIVE VENTRICULAR PACING RESULTING IN PACING WITHOUT CAPTURE. IN ADDITION, SOME NSO EPISODES WERE DUE TO MYOPOTENTIAL OVERSENSING. DEVICE REPROGRAMMING IS ANTICIPATED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668555 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC. CD3371-40QC A000090522

    Patients

    Seq Age Sex Outcome Treatment
    1