BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3052795 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03495
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 LOW SHOCK IMPEDANCE MEASUREMENT LESS THAN 20 OHMS WAS OBSERVED. ALL OTHER LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. A SMALL AMOUNT OF NOISE WAS DETECTED ON THE SHOCK AND RATE/SENSE LEADS, HOWEVER, WAS NOT SENSED BY THE DEVICE. THE PATIENT WITH THIS DEVICE SYSTEM REPORTEDLY USED A MUSCLE STIMULATION DEVICE DURING THAT TIME. ALL PRECEEDING AND FOLLOWING SHOCK IMPEDANCE LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156549 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 0292| E140