BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 9616824 · Received January 22, 2020

    Report

    Report Number
    2938836-2020-00508
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Report Date
    May 10, 2022
    Manufacturer
    ABBOTT
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G3: DATE RECEIVED BY MANUFACTURER IN MDR-2020-02603-01 SUBMITTED ON 10 MAY 2022 SHOULD HAVE BEEN 10 MAY 2022 INSTEAD OF BEING EMPTY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS 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

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT DUE TO ELECTROMAGNETIC INTERFERENCE FROM A LEFT-VENTRICULAR ASSIST DEVICE (LVAD), THE DEVICE COULD NOT BE INTERROGATED. NO ADDITIONAL INFORMATION WAS AVAILABLE. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ARTICLE, TITLED ¿PREVALENCE OF ELECTROMAGNETIC INTERFERENCE FROM LEFT VENTRICULAR ASSIST DEVICES IN PATIENTS WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/PACEMAKERS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82569 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ABBOTT UNIFY
    82596 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ABBOTT UNIFY

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown