BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 3781731 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09889
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    September 23, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO A SUSPECTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259643 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention 1582/65, RJ019899