BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL VR, DF4 CONNECTOR

    MDR report key: 3891203 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03532
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 26, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    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 RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED FOR EVAL AFTER RECEIVING AN ALERT. INTERROGATION OF THE ICD REVEALED AN OUT OF RANGE HV IMPEDANCE. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28194 CURRENT ACCEL VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D CD1215-36Q

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR