BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3212567 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08906
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. 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 DURING A ROUTINE FOLLOW-UP APPOINTMENT, SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS WERE NOTED ON THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD. AS A RESULT, A LEAD REVISION WAS PERFORMED. THE NEW RV LEAD ALSO NOTED IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS. A NEW DEVICE WAS IMPLANTED AND THE SHOCK IMPEDANCE MEASUREMENTS REMAINED THE SAME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312449 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P142

    Patients

    Seq Age Sex Outcome Treatment
    1