BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1970247 · Received January 14, 2011

    Report

    Report Number
    1000165971-2011-00020
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 27, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., 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

    (B)(4), 2011. 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 PROCEDURE OF THE PACEMAKER INVOLVED IN THIS MDR REPORT, THE LEADS WERE INSERTED FIRST AND THE MEASUREMENTS WERE NORMAL. THE PACEMAKER WAS THEN CONNECTED TO THE LEADS AND PACING WAS CONFIRMED FOR BOTH SIDES (ATRIAL AND VENTRICULAR); HOWEVER, P WAVE UNDERSENSING WAS NOTED (ATRIAL SENSING WAS PROGRAMMED AT 0.6 MV). LEAD IMPEDANCE TEST WAS NORMAL (ATRIAL: 503 OHMS, VENTRICULAR: 780 OHMS). A SENSING TEST WAS CARRIED OUT BUT NO SPONTANEOUS BEATS WERE CONFIRMED AT THE VENTRICULAR SIDE AND ONLY VENTRICULAR PACING WAS OBSERVED. AT THE ATRIAL SIDE, NOISE SENSING WAS DETECTED. THE SENSING TEST WAS CARRIED OUT AGAIN BUT WITH THE SAME RESULTS. THE DEVICE WAS NOT IMPLANTED AND RETURNED FOR ANALYSIS; IT WAS REPORTED THAT NO PATIENT FILE WAS AVAILABLE. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention