BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR ICD, US

    MDR report key: 9405895 · Received December 3, 2019

    Report

    Report Number
    2017865-2019-17383
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    November 12, 2019
    Report Date
    February 24, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVZ
    UDI-DI
    05414734508094
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 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.CORRECTION - A3 - PATIENT DATE OF BIRTH SHOULD BE JAN 21, 1947 NOT BLANK.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. THE DEVICE IS INCLUDED IN THE BATTERY PERFORMANCE ALERT ADVISORY ISSUED BY ABBOTT ON 28 AUGUST 2017.

    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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195940 FORTIFY ASSURA DR ICD, US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NVZ ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2357-40Q A000003329 05414734508094

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention