BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, U1.6 SJ4 US

    MDR report key: 8621260 · Received May 17, 2019

    Report

    Report Number
    2017865-2019-08250
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 30, 2019
    Report Date
    September 4, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734504348
    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
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE DEVICE IS INCLUDED IN THE BATTERY PERFORMANCE ALERT ADVISORY ISSUED BY ABBOTT ON 28 AUGUST 2017.

    Additional Manufacturer Narrative · 1

    PREMATURE BATTERY DEPLETION WAS CONFIRMED BY ANALYSIS. NO SOURCES OF HIGH CURRENT WERE NOTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS CONSISTENT WITH LITHIUM (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. PREMATURE BATTERY DEPLETION WAS ALSO SUSPECTED. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES AND WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415142 FORTIFY VR, U1.6 SJ4 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD1231-40Q 3965352 05414734504348

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention