BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1830979 · Received September 7, 2010

    Report

    Report Number
    1000165971-2010-00881
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 16, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANTATION OF THE PACEMAKER INVOLVED IN THIS MDR REPORT, THE VENTRICULAR SETSCREW COULD NOT BE TIGHTENED PROPERLY AND THE LEADS WERE ATTACHED INCORRECTLY. A RE-INTERVENTION WAS PERFORMED 4 DAYS LATER BUT VENTRICULAR SETSCREW COULD NOT BE TIGHTENED PROPERLY ANYMORE. THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANOTHER PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY DR 2440

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention