BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ST VR

    MDR report key: 4173881 · Received October 15, 2014

    Report

    Report Number
    2938836-2014-16662
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 21, 2014
    Report Date
    July 19, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-0115-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    EVALUATION DESCRIPTION: THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL WAS ORIGINALLY SUBMITTED BACK IN 2014. FOLLOW-UP TO THIS INITIAL WAS SUBMITTED IN 2018 (2938836-2018-02780) AGAIN AS INITIAL INSTEAD OF SUPPLEMENT REPORT. WE ARE RE-SUBMITTING THE INITIAL REPORT SUBMITTED IN 2018 AS SUPPLEMENT UNDER PREVIOUSLY SUBMITTED INITIAL MDR IN 2014. CORRECTION: MANUFACTURER REPORT 2938836-2014-16662, SHOULD NOT HAVE BEEN REPORTED AS A MEDICAL DEVICE REPORT (MDR) AS THE PRODUCT HAS NOT BEEN APPROVED BY FDA AND IS PART OF INVESTIGATION DEVICE EXEMPTION (IDE).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS HOSPITALIZED FOR INAPPROPRIATE SHOCK AND SYNCOPE. TWO DAYS LATER, PATIENT DEVICE WAS NOT ABLE TO BE INTERROGATED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED AFTER SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO INTERROGATE. PATIENT WAS IN GOOD CONDITION AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655728 FORTIFY ST VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1235-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention