BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3201668 · Received June 28, 2013

    Report

    Report Number
    1000165971-2013-00314
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THE IMPLANTATION OF THE SUBJECT DEVICE, A CONNECTION ISSUE RELATIVE TO THE VENTRICULAR CHANNEL WAS REPORTED; THERE WAS NO CLICKING OF THE ASSOCIATED TORQUE-LIMITING SCREWDRIVER. THE FOLLOWING DAY A F/U OF THE DEVICE REVEALED A HIGH IMPEDANCE MEASUREMENT >3000 OHMS. AN X-RAY REVEALED THAT THE LEAD WAS NOT FULLY INSERTED INTO THE PACEMAKER PORT. A RE-INTERVENTION WAS PERFORMED AND PSA MEASUREMENTS ON THE LEAD WERE REPORTEDLY NORMAL. ANOTHER PACEMAKER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295491 REPLY NVZ SORIN GROUP ITALIA S.R.L. REPLY DR 2698

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention