BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT PLUS DR, DF4 CONNECTOR

    MDR report key: 4091548 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04857
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 31, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS REC'D. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: THE PACING CAPTURE ANOMALY WAS NOT VERIFIED. THE DEVICE WAS TESTED ON THE BENCH AND IN THE ATE SYSTEM AND NO ANOMALY WAS DETECTED. THE DEVICE MET ALL OF THE TEST SPECIFICATIONS OF THE ATE SYSTEM. THE DEVICE TESTED NORMAL. THE CAUSE OF THE ANOMALY WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DEVICE EXHIBITED HIGH THRESHOLD. THIS DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22673 CURRENT PLUS DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD CD2211-36Q

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR