BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, U1.6 SJ4 US

    MDR report key: 4863408 · Received June 23, 2015

    Report

    Report Number
    2938836-2015-27328
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 20, 2015
    Report Date
    June 6, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z-0115- 2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CODE AVAILABLE; THE REPORTED INABILITY TO INTERROGATE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO PREMATURE BATTERY DEPLETION. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. WITH AN EXTERNAL POWER SUPPLY ATTACHED, THE DEVICE FUNCTIONED NORMALLY. NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND ANALYSIS COULD NOT CONCLUSIVELY DETERMINE A ROOT CAUSE FOR THE PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A PATIENT PRESENTED FOR A DEVICE CHECK, THE DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT RECEIVED NO COMPLICATIONS FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405051 FORTIFY DR, U1.6 SJ4 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2231-40Q 3251592

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R