BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3211612 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08486
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 14, 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

    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 ROUTINE TESTING, THIS RIGHT VENTRICULAR (RV) LEAD MEASURED A SHOCK IMPEDANCE OF ABOUT 170 OHMS. ADDITIONALLY, THE PACE IMPEDANCE MEASUREMENT WAS GREATER THAN 2000 OHMS. ALL OTHER PARAMETERS ARE NORMAL AND THERE WAS NO NOISE ON THE SHOCK CHANNEL. A REVISION PROCEDURE WAS PERFORMED 11 DAYS LATER, AND A DISCONNECTED DISTAL COIL WAS REPORTED. THE SOURCE OF THE OUT OF RANGE IMPEDANCE MEASUREMENTS WAS DUE TO A CONNECTION ISSUE WITH THIS PULSE GENERATOR. ALL PRODUCTS WERE SUCCESSFULLY RECONNECTED WITH NORMAL MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311719 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND P165

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R K187| MISMATCH