BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 4240775 · Received November 10, 2014

    Report

    Report Number
    2938836-2014-17720
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    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 THE PATIENT PRESENTED WITH AUTO MODE SWITCH EPISODES DUE TO OVERSENSING. THE DEVICE WILL BE REPROGRAMMED AND PATIENT WILL CONTINUE TO BE MONITORED REMOTELY. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723887 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR