BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE ACCEL CRT-D,SJ4 CONNECTOR

    MDR report key: 1831093 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03615
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 7, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    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. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT WAS VERIFIED IN THE LABORATORY. ANALYSIS FOUND THE DEVICE'S FUNCTIONALITY WAS NORMAL, AND NO HIGH CURRENT MEASUREMENTS WERE DETECTED. THE POWER CONSUMPTION MEASUREMENTS OF THE DEVICE WERE NORMAL. THE BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER ANALYSIS. AN INTERNAL ANOMALY WAS FOUND THAT RESULTED IN THE PREMATURE BATTERY DEPLETION REPORTED IN THE FIELD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER THAT THEY FOUND TRANSFER SET LEAKAGE AFTER CLOSING IT. THIS PROBLEM WAS FOUND DURING PATIENT USE. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE ACCEL CRT-D,SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3215-36

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention