BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1936265 · Received December 15, 2010

    Report

    Report Number
    1000165971-2010-01021
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 1, 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)(6) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THIS ISSUE WAS OBSERVED AT A REOPERATION TO REPOSITION THE DISLODGED ATRIAL LEAD. WHEN THE PACEMAKER WAS TAKEN OUT FROM THE POCKET, BLOOD WAS NOTED WITHIN THE PACEMAKER'S VENTRICULAR PORT AS WELL AS WITHIN THE VENTRICULAR LEAD. THE SYSTEM WAS REPLACED (PACEMAKER AND VENTRICULAR LEAD) AND THE ATRIAL LEAD WAS REPOSITIONED. THE PACEMAKER INVOLVED IN THIS MDR REPORT WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention