BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3122244 · Received May 17, 2013

    Report

    Report Number
    1000165971-2013-00255
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2013, THE DISPLAYED RESIDUAL LONGEVITY WAS 8 MONTHS. THREE MONTHS LATER, THE DEVICE HAD REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) AND WAS OPERATING IN VVI MODE. THE RESIDUAL LONGEVITY DISPLAYED AT THAT TIME WAS BELOW 3 MONTHS. THE DEVICE AND THE VENTRICULAR LEAD WERE THEN REPLACED ON (B)(6) 2013. AN EXPLANTATION CONCERNING THE DISPLAYED RESIDUAL LONGEVITY IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218831 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention