BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, U1.6 DF1 ID

    MDR report key: 8802900 · Received July 18, 2019

    Report

    Report Number
    2938836-2019-05960
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 25, 2019
    Report Date
    October 21, 2019
    Manufacturer
    ABBOTT CRM
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    Z-0003-2018; Z-0115-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    PREMATURE BATTERY DEPLETION WAS CONFIRMED BY ANALYSIS. A DEVICE EVALUATION WAS PERFORMED, AND NO SOURCES OF HIGH CURRENT WERE NOTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS CONSISTENT WITH LI CLUSTER FORMATION. FROM THESE ANALYSES, IN THE ABSENCE OF HIGH CURRENT DRAW, IT IS PROBABLE THAT THE PREMATURE BATTERY DEPLETION WAS CAUSED BY A LITHIUM CLUSTER INDUCED SHORT CIRCUIT. LI CLUSTERS ARE A KNOWN DEPLETION MECHANISM FOR THESE ADVISORY PRODUCTS THAT HAS BEEN INVESTIGATED AND ASSOCIATED WITH A FIELD ACTION IN OCTOBER 2016.

    Description of Event or Problem · 1

    FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597118 FORTIFY VR, U1.6 DF1 ID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ABBOTT CRM CD1233-40 4221441

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R