BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFYASSURA DR

    MDR report key: 6218565 · Received January 3, 2017

    Report

    Report Number
    2938836-2017-00133
    Event Type
    Injury
    Date Received
    January 3, 2017
    Date of Event
    December 6, 2016
    Report Date
    June 16, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    Z-0115-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE REPORTED INABILITY TO COMMUNICATE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO LOW BATTERY VOLTAGE. PREMATURE BATTERY DEPLETION WAS CONFIRMED BY ANALYSIS. BENCH TESTING ON THE DEVICE WAS PERFORMED, AND NO SOURCES OF HIGH CURRENT WERE NOTED. IN FURTHER ANALYSIS OF THE BATTERY, LITHIUM CLUSTERS WERE OBSERVED, BUT AT THE TIME OF ANALYSIS, THE CLUSTERS DID NOT APPEAR TO BE IN A LOCATION OR SIZE THAT WOULD BE SUFFICIENT TO CAUSE AN INTERNAL SHORT OF THE BATTERY. AS A RESULT, THE CAUSE OF THE PREMATURE BATTERY DEPLETION COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, FROM THESE ANALYSES, IN THE ABSENCE OF OTHER ROOT CAUSES, IT IS PROBABLE THAT THE PREMATURE BATTERY DEPLETION WAS CAUSED BY A LITHIUM CLUSTER INDUCED SHORT CIRCUIT. THE DEVICE IS INCLUDED IN THE PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ADVISORY NOTICE ISSUED BY ST. JUDE MEDICAL ON 11 OCTOBER 2016. ADDITIONAL INFORMATION: BRAND NAME: FORTIFY ASSURA DR; PMA/510(K) #: P910023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. THE PATIENT WAS ASYMPTOMATIC. THE BATTERY HAD 5 YEARS OF LONGEVITY IN (B)(6) 2016 AND THEN 1.6 YEARS OF LONGEVITY IN (B)(6) 2016. NOW, THE IN-CLINIC INTERROGATION SHOWS THAT THE DEVICE CANNOT COMMUNICATE WITH THE PROGRAMMER. RAPID PREMATURE BATTERY DEPLETION WAS NOTED. DEVICE WAS EXPLANTED AND REPLACED WITHOUT ANY ISSUES. THE PATIENT WAS OUTPATIENT STATUS AND WENT HOME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564 FORTIFYASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2257-40

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention