BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3971340 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14837
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2013
    Report Date
    May 13, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN AND NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE PACING LEAD IMPEDANCE AND HIGH PACING THRESHOLD MEASUREMENTS. SUBSEQUENTLY, THE RV LEAD WAS SURGICALLY ABANDONED AND THE PATIENT'S ICD WAS UPGRADED TO A DUAL CHAMBER DEVICE. THE EXPLANTED ICD WILL NOT BE RETURNED AS IT HAS BEEN DISCARDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446477 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E161

    Patients

    Seq Age Sex Outcome Treatment
    1 263 MO Hospitalization| L| R E161| MISMATCH