BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE ACCEL CRT-D

    MDR report key: 1954798 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00521
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 6, 2010
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF OUTPUT ANOMALY COULD NOT BE CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND FOUND TO BE NORMAL. NO SENSE OR PACE ANOMALIES WERE OBSERVED WITH THE DEVICE IN THE LABORATORY. THE CAUSE OF THE REPORTED FIELD EVENT REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    DURING A VT ABLATION PROCEDURE, THE DEVICE WAS REPROGRAMMED DUE TO DISLODGMENT OF COMPETITOR LEAD. THE PATIENT ARRESTED JUST AFTER REPROGRAMMING. THE PATIENT HAD NO INTRINSIC RHYTHM AND WAS TOTALLY DEPENDENT ON PACING. FIVE MONTHS PREVIOUS, THE PATIENT ARRESTED DURING A FOLLOW-UP, AND A NEW SENSE/PACE LEAD WAS IMPLANTED. NO FURTHER PROBLEMS WERE SEEN UNTIL THE ABLATION PROCEDURE. THE PHYSICIAN SUSPECTED THAT THERE WAS A PROBLEM WITH THE ICD AND REPLACED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE ACCEL CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3215-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention