BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1994384 · Received January 14, 2011

    Report

    Report Number
    1000165971-2011-00016
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 24, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING A PACEMAKER REPLACEMENT PROCEDURE, THE SUBJECT DEVICE WAS CONNECTED TO THE PACING LEADS WITHOUT DIFFICULTY. CAPTURE FAILURE WAS SUBSEQUENTLY IDENTIFIED. THE PHYSICIAN DISCONNECTED THE DEVICE FROM THE LEADS WITHOUT DIFFICULTIES AND PSA MEASUREMENTS ON THE LEADS WERE NORMAL. RECONNECTION OF THE SUBJECT DEVICE YIELDED AGAIN CAPTURE FAILURE. THIS WAS AGAIN REPEATED TWO MORE TIME WITH THE SAME RESULTS, SO ANOTHER PACEMAKER WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY D 2488

    Patients

    Seq Age Sex Outcome Treatment
    1