BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 1936311 · Received December 15, 2010

    Report

    Report Number
    9610579-2010-00635
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 1, 2010
    Manufacturer
    SORIN CRM
    Product Code
    DXY
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, AFTER MORE THAN 9 YEARS OF IMPLANTATION, THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS FOUND IN STANDBY MODE ON (B)(6) 2010; SOME RAPID VARIATIONS WERE NOTED ON THE BATTERY IMPEDANCE CURVE. THE PATIENT SAID THAT HE WAS WEARING A MAGNETIC STONE INSIDE HIS SHIRT POCKET IN FRONT OF THE PACEMAKER POCKET. THE PACEMAKER WAS REPROGRAMMED TO DDI MODE AND THE PATIENT WAS SENT HOME. ON (B)(6) 2010, THE PACEMAKER WAS FOUND AGAIN IN STANDBY MODE WITH A BATTERY IMPEDANCE OF 10KO, I.E., THE ELECTIVE REPLACEMENT INDICATOR WAS REACHED; THEREFORE, THE REPLACEMENT PROCEDURE WAS SCHEDULED. THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS RETURNED FOR ANALYSIS TO INVESTIGATE WHETHER THE RAPID INCREASE OF THE INTERNAL BATTERY IMPEDANCE COULD BE RELATED TO THE MAGNETIC STONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT DXY SORIN CRM TALENT DR 213 S011115

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention