BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2133649 · Received June 16, 2011

    Report

    Report Number
    1000165971-2011-00212
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SORIN C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    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 MFG AND USED OUTSIDE THE U.S. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    AFTER IMPLANTATION OF THE SUBJECT DEVICE, THE PT REPORTED FEELING FAINT, WHICH THE PHYSICIAN INDICATED WAS DUE TO CAPTURE FAILURE. IMPROPER LEAD CONNECTION OF THE LEADS TO THE PACEMAKER WAS SUSPECTED BY THE PHYSICIAN. "DURING REINTERVENTION, THE PHYSICIAN CHANGED THE LEAD BUT THERE WAS STILL NO CAPTURE." ANOTHER PACEMAKER WAS IMPLANTED, WHICH SOLVED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN C.R.M., S.R.L. REPLY DR 2512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention