BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3904559 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10219
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF 2000 OHMS. THE PATIENT ALSO HAD FOUR VENTRICULAR FIBRILLATION EPISODES DUE TO OVERSENSED NOISE ON THEIR COMPETITOR RIGHT VENTRICULAR (RV) LEAD, WHICH LED TO THE PATIENT RECEIVING 24 INAPPROPRIATE SHOCKS. ADDITIONAL INFORMATION FROM THE FIELD REVEALED THAT THE RV LEAD WAS FRACTURED, HOWEVER, THIS WAS NOT CONFIRMED THROUGH X-RAY OR FLUOROSCOPY. A REVISION PROCEDURE WAS PERFORMED AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. THE ICD CONTINUES TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383015 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R MISMATCH| E163| H197