BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALTRUA

    MDR report key: 1727323 · Received June 17, 2010

    Report

    Report Number
    2124215-2010-12770
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR TESTING. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER PATIENT ARRESTED AND SUBSEQUENTLY PASSED AWAY SEVERAL HOURS POST-IMPLANT. THIS DEVICE HAD BEEN IMPLANTED ON THE PATIENT'S RIGHT SIDE WITH NO REPORTED COMPLICATIONS. FOUR DAYS PREVIOUSLY (DURING THE ORIGINAL LEFT-SIDED IMPLANT PROCEDURE), THE PATIENT HAD ARRESTED, WENT INTO VENTRICULAR FIBRILLATION (VF) AND CHEST COMPRESSIONS WERE REQUIRED. IT WAS REPORTED THAT, AS A RESULT OF THIS, THE PHYSICIAN WAS CONCERNED WITH POSSIBLE STERILITY ISSUES (POTENTIALLY A FUTURE INFECTION) AND THUS ELECTED TO IMPLANT A NEW PACEMAKER ON THE RIGHT SIDE ONCE THE PATIENT HAD STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR DXY GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| R 4457| S603| 4469| 4471| 4470| 4136