BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3040831 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03347
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    PHYSICIAN

    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 WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED INAPPROPRIATE SHOCKS FOR SINUS TACHYCARDIA. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO REVIEW THE THERAPY EPISODES. TS DISCUSSED WHY THERAPY HAD BEEN GIVEN AND THAT SUSTAINED RATE DURATION (SRD) COULD BE PROGRAMMED OFF IN EFFORT TO HELP PREVENT FUTURE INAPPROPRIATE THERAPY. TS NOTED THAT THERAPY HAD BEEN EXHAUSTED. OF NOTE, THE PATIENT REPORTED THAT THEY HAD MISSED THEIR DOSE OF COREG. ADDITIONAL INFORMATION FROM THE FR INDICATED THAT SRD WAS PROGRAMMED TO OFF. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144320 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E141

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR MISMATCH| E141