BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3211037 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07808
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 FOLLOW UP VISIT, THE PATIENT WITH THIS DEVICE AND RIGHT VENTRICULAR LEAD REPORTED HAVING RECEIVED TWO INAPPROPRIATE SHOCKS. INTERROGATION REVEALED NUMEROUS EPISODES. PACING IMPEDANCE MEASUREMENTS WERE HIGH OUT OF RANGE. SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL. A REVIEW OF THE DATA REVEALED THAT THIS LEAD HAS SOME OUT OF RANGE AND SOME NORMAL IMPEDANCE MEASUREMENTS. INSULATION DAMAGE OR A LEAD FRACTURE WERE SUSPECTED. THE DETECTION PARAMETERS WERE REPROGRAMMED AND A REVISION PROCEDURE IS INTENDED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED: A REVISION PROCEDURE WAS PERFORMED. THE RIGHT VENTRICULAR LEAD PIN WAS CLEANED AND NORMAL VALUES WERE OBTAINED WITH THE PACING SYSTEM ANALYZER. SAME NORMAL MEASUREMENTS WERE OBTAINED WITH THE DEVICE. IT WAS THOUGHT THERE WAS CONTAMINATION FROM THE LEAD PIN THAT CONTRIBUTED TO THE REPORTED OBSERVATIONS AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310961 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P142

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0296| 4096| MISMATCH| P142