BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 4021801 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14473
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 17, 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 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 A MERLIN.NET TRANSMISSION REVEALED AN ABNORMALLY SHORT CHARGE TIME. PERFORMING A CAPACITOR MAINTENANCE TO CONFIRM THE MAX CHARGE TIME WAS RECOMMENDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499472 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 49 YR