BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 4132142 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17226
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH  SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE OUT OF RANGE MEASUREMENTS WERE NOT RECREATED WITH VAL SALVA AND ISOMETRICS. NO NOISE NOTED ON ELECTROGRAM (EGM). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND DELIVERY OF HIGH ENERGY SHOCK. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611263 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND N141

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR N141| H177| 4968| 4135| 4046| 1861| 1851| 1388T| 0145| 0295| N119| MISMATCH| 0184