BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 2962830 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00127
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 9, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 THE PATIENT PRESENTED IN THE E.R. AFTER RECEIVING SHOCKS. INITIAL DIAGNOSIS WAS SVT IN THE MONITOR ZONE. THE SVT WAS RE-DIAGNOSED SEVERAL TIMES UNTIL THE RHYTHM ACCELERATED AND VF WAS DIAGNOSED. A SHOCK WAS DELIVERED WHICH PUT THE PATIENT INTO VT. THE RHYTHM CONVERTED BACK TO SVT BUT RE-DIAGNOSIS CONTINUED AND ADDITIONAL SHOCKS WERE DELIVERED. RHYTHM EVENTUALLY SLOWED BELOW RATE DETECTION. DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64965 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention