BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT SR RF OUS

    MDR report key: 3223214 · Received July 12, 2013

    Report

    Report Number
    2017865-2013-04930
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 11, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND THAT A SOLDER JOINT ANOMALY WHICH LIKELY CONTRIBUTED TO THE REPORTED ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ON HIS CHEST IN MARCH. THE PULSE GENERATOR COULD NOT BE INTERROGATED ON (B)(6) 2013. THE DEVICE EXHIBITED BACKUP OPERATION AND WAS EXPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323019 ACCENT SR RF OUS IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM1210 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention