BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3012478 · Received March 15, 2013

    Report

    Report Number
    1000165971-2013-00135
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 26, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MARCH 15, 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORTS 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

    UPON THE REPLACEMENT OF A PACEMAKER (END OF LIFE) WITH THE SUBJECT REPLY ON (B)(6) 2013, THE PHYSICIAN HAD DIFFICULTIES TO INSERT THE EXISTING V LEAD IN THE V CHANNEL OF THE PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110571 REPLY NVZ SORIN CRM S.R.L. REPLY D 2661

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention