BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR RF

    MDR report key: 4191757 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04577
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    September 13, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS FUNCTIONING WITHIN NORMAL ELECTRICAL CHARACTERISTICS INCLUDING AT THERMAL AND MECHANICAL STRESSING. ECG PRINT OUT DID NOT SHOW ANY NOISE DURING THE ENTIRE PERFORMANCE TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED NOISE WAS OBSERVED WHEN TESTING THE PULSE GENERATOR DURING FOLLOW UP. LEAD FRACTURE, CURRENT LEAKAGE AND LOOSE LEAD PIN WERE SUSPECTED. HOWEVER, THE CAUSE OF THE NOISE COULD NOT BE DETERMINED. THEREFORE, BOTH LEAD AND PULSE GENERATOR WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29798 ACCENT DR RF IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD M2212

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention (B)(4)