BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS VR, DF-4 CONNECTOR

    MDR report key: 4210652 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17245
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 12, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POCKET REVISION WAS PERFORMED DUE TO A HEMATOMA. PATIENT CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692810 CURRENT PLUS VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention