BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3760897 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08848
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    August 15, 2012
    Report Date
    February 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE PACING IMPEDANCES GREATER THAN 2,000 OHMS ALONG WITH AN INCREASE IN THRESHOLDS. THE PATIENT WAS SENT TO GET A CHEST X-RAY. IT WAS REPORTED THAT DURING THE LAST 1.5 MONTHS THE PATIENT WAS MOVING AND DOING MORE LIFTING THAN NORMAL. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239829 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E140

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R E140| 0295