BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT SR RF CUS

    MDR report key: 4151060 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-06590
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO WAS PROVIDED BY MFR, 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. EVAL DESCRIPTION: THE FIELD EVENT DIFFICULT TO INTERROGATE WAS CONFIRMED. DEVICE FAILED TO COMMUNICATE WITH A MERLIN PROGRAMMER VIA RF, BUT COULD COMMUNICATE VIE UEP AND PASSES BANDWIDTH TESTS. THE CAUSE OF THE INTERROGATION ANOMALY WAS SUSPECTED TO BE AN ANOMALOUS RF MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS DIFFICULT TO INTERROGATE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31900 ACCENT SR RF CUS IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD PM1210

    Patients

    Seq Age Sex Outcome Treatment
    1