BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT DR RF

    MDR report key: 3911000 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12978
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 PATIENT COMPLAINED OF INCREASING PAIN AT THE DEVICE SITE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386153 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention