BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR ICD_IDE_US

    MDR report key: 6195128 · Received December 21, 2016

    Report

    Report Number
    2938836-2016-20176
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    December 14, 2016
    Report Date
    May 11, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. THE DEVICE WAS INTERROGATED WITH A PROGRAMMER AND HAD NOT REACHED ERI. NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION RECEIVED, THE DEVICE WAS PROPHYLACTICALLY REMOVED AND THERE IS NO ALLEGED MALFUNCTION OF THE PRODUCT. SHOULD THE DEVICE BE RETURNED AND THE ANALYSIS RESULTS INDICATE AN ANOMALY A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    FOLLOWING THE ADVISORY FOR PREMATURE BATTERY DEPLETION WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, ALTHOUGH THERE WAS NO ERI ALERT OR ALLEGATION OF PREMATURE BATTERY DEPLETION, THE DEVICE WAS EXPLANTED PROPHYLACTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843674 FORTIFY ASSURA VR ICD_IDE_US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. CD1257-40Q 3882309

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention