BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGENCY SC+

    MDR report key: 1896454 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05246
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    July 5, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    P880006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT, THE PULSE GENERATOR SOMETIMES PACED AT THE PROGRAMMED RATE OF 60 PULSES PER MINUTE (PPM), AND SOMETIMES PACED AT 40 PPM. THE DEVICE WAS RECONNECTED TO THE LEADS, BUT THE SAME BEHAVIOR CONTINUED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REGENCY SC+ IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2402L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention