BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RP

    MDR report key: 4191758 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04573
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    October 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION 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. EVALUATION: THE REPORTED FIELD EVENT OF NOISE COULD NOT BE CONFIRMED IN THE LABORATORY. NO ANOMALIES WERE FOUND THAT WOULD CAUSE THE REPORTED NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED THAT THE PULSE GENERATOR HEADER WAS DAMAGED WHICH WAS CAUSING NOISE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28403 ACCENT DR RP IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD PM2210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention