BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3213100 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10446
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 21, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    D970003/S106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION INTO THIS INCIDENT IS CURRENTLY BEING CONDUCTED. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ---

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REPLACEMENT PROCEDURE, A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD WAS UNABLE TO BE CONNECTED TO A BOSTON SCIENTIFIC PACEMAKER WHICH LED TO A LOSS OF PACING AND THE PATIENT EXPERIENCED CARDIAC ARREST. THE PATIENT WAS REANIMATED. THE MODEL AND SERIAL INFORMATION ON THE BOSTON SCIENTIFIC PACEMAKER IS CURRENTLY UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THIS INCIDENT WAS PREVIOUSLY REPORTED IN 2011 UNDER MDR REPORT NUMBER 2124215-2011-00963.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312180 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R