BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2850579 · Received November 16, 2012

    Report

    Report Number
    1000165971-2012-00427
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    May 28, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE PHYSICIAN REPORTED THAT THE IMPLANTED PACING SYSTEM WAS NOT FUNCTIONING CORRECTLY, AND THIS WAS EVIDENCED BY SYNCOPE EPISODES AND INAPPROPRIATE PACING THERAPY. THREE SEPARATE RE-INTERVENTIONS WERE PERFORMED IN AN ATTEMPT TO CORRECT THE ISSUE. ULTIMATELY, A LEAD WAS REPOSITIONED, AND THE SUBJECT DEVICE WAS REPLACED BECAUSE THERE WAS BLOOD INSIDE THE HEADER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2598

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention