BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2850747 · Received November 23, 2012

    Report

    Report Number
    1000165971-2012-00460
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 15, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION OF THE PACEMAKER INVOLVED IN THIS MDR REPORT AND AFTER PLACING IT INTO THE POCKET, SOME BLEEDING WAS CONFIRMED; THEREFORE THE PHYSICIAN STOPPED BLOOD BY USING AN ELECTROCAUTERY. AT THE POST-IMPLANT CHECK, TELEMETRY ERRORS WERE OBSERVED WITH AN INITIAL PROGRAMMER. THEREFORE, THE PACEMAKER WAS CHECKED AGAIN WITH OTHER PROGRAMMERS; INTERROGATION WAS SUCCESSFULLY COMPLETED, BUT THRESHOLD TEST COULD NOT BE PERFORMED EVEN AFTER SEVERAL ATTEMPTS. THE DEVICE WAS NOT KEPT IMPLANTED AND RETURNED FOR ANALYSIS. ANOTHER PACEMAKER WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention