BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 3053558 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05047
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WHEN ATTACHED TO THE DEVICE, EVEN AFTER RECONNECTION. IT WAS ALSO NOTED THAT THE ELECTROGRAM APPEARED ABNORMAL WITH NOISE AND A FLAT SHOCK CHANNEL. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED A NEW LEAD WITH NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155588 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 4470| 0296| 0293| E142