BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2780081 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12160
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 30, 2012
    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), HIGH OUT OF RANGE SHOCK IMPEDANCES OF GREATER THAN 125 OHMS WERE OBSERVED. IT WAS NOTED THAT SHOCK IMPEDANCES WERE APPROXIMATELY 101 OHMS WITH THE PREVIOUS DEVICE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED TESTING SHOCK IMPEDANCES IN TRIAD CONFIGURATION AND THEN PERFORMING A SAVE TO DISK AND MEMORY DUMP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR T177| 0185