BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP

    MDR report key: 11045936 · Received December 21, 2020

    Report

    Report Number
    2938836-2020-09787
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ABBOTT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. 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, POST-SENSED T-WAVE OVERSENSING WAS OBSERVED AND WAS RESOLVED BY PROGRAMMING BRADYCARDIA SENSITIVITY. DURING ANOTHER FOLLOW-UP, PRE-SYNCOPE DUE TO PACING INHIBITION WAS REPORTED DUE TO NON-SUSTAINED OVERSENSING (NSRVOS) DUE TO EXTERNAL NOISE. DEFIBRILLATION THERAPY WAS NOT DELIVERED DUE TO CORRECT INTERPRETATION OF OVERSENSING BY THE DEVICE. THE EVENT WAS RESOLVED BY REPROGRAMMING THE DEVICE. THE PATIENT WAS IN STABLE CONDITION. DETAILS ARE LISTED IN THE ARTICLE TITLED "DEALING WITH RV-OVERSENSING; SEPARATE SENSITIVITY SETTINGS FOR BRADY AND TACHY SENSING. J CARDIOVASC ELECTROPHYSIOL. 2020; 1¿ 3. HTTPS://DOI.ORG/10.1111/JCE.14823".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517811 QUADRA ASSURA MP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ABBOTT QUADRA ASSURA MP

    Patients

    Seq Age Sex Outcome Treatment
    1