BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3041098 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-05170
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WENT TO THE EMERGENCY ROOM AFTER RECEIVING SHOCKS FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). INTERROGATION OF THE DEVICE FOUND THAT BOTH ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS WERE DELIVERED UNTIL THERAPY WAS EXHAUSTED. WHEN THE RHYTHM WAS INITIALLY DETECTED, THERAPY WAS WITHHELD AS THE RHYTHM ID ALGORITHM CLASSIFIED THE RHYTHM AS CORRELATED, INDICATING THAT THE RHYTHM WAS CLASSIFIED AS SUPRAVENTRICULAR TACHYCARDIA (SVT). ONCE THE SUSTAINED RATE DURATION (SRD) TIMED OUT, THE DEVICE DELIVERED THERAPY. THE DELIVERED THERAPY DID NOT CONVERT THE RHYTHM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR TECHNICAL ASSISTANCE. A TS CONSULTANT DISCUSSED PROGRAMMING CHANGES THAT COULD BE MADE IF THE PHYSICIAN DID NOT WANT THERAPY TO BE DELIVERED. THERE IS NO ATRIAL LEAD SO IT CANNOT BE CONFIRMED IF THIS RHYTHM WAS AN ATRIAL ARRHYTHMIA OR A TRUE VENTRICULAR TACHYCARDIA. THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142947 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 0185| T135| E141