BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3190161 · Received June 21, 2013

    Report

    Report Number
    1000165971-2013-00307
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    SORIN GROUP ITALIA 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

    DATE (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

    DURING AN IMPLANT ATTEMPT OF THE SUBJECT DEVICE, CONNECTION DIFFICULTIES IN ATRIAL CHANNEL WERE INCURRED. SPECIFICALLY, THE PHYSICIAN REPORTED THAT CLICKING OF THE ASSOCIATED SCREWDRIVER COULD NOT BE OBTAINED, AND IT WAS THEN NOT POSSIBLE TO LOOSEN THE ASSOCIATED SET-SCREW. THE PHYSICIAN BROKEN THE HEADER OF THE PACEMAKER IN AN ATTEMPT TO DISCONNECT THE LEAD, BUT WAS UNSUCCESSFUL. A NEW LEAD AND PACEMAKER WERE SUBSEQUENTLY IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283137 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2675

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention