BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1971464 · Received January 21, 2011

    Report

    Report Number
    1000165971-2011-00032
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 5, 2010
    Report Date
    January 4, 2011
    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
    UK
    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

    CONNECTION ISSUES WITH THE VENTRICULAR LEAD WERE REPORTED DURING THE IMPLANT PROCEDURE. APPROPRIATE CONNECTION COULD NOT BE CONFIRMED. ANOTHER PACEMAKER WAS SUBSEQUENTLY 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 2448

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention