BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1930047 · Received November 18, 2010

    Report

    Report Number
    1000165971-2010-00978
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2010. 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 FOLLOW-UP ON (B)(6), THE PHYSICIAN COMPLAINS THAT SOME DATA SUCH AS A LEAD MEASUREMENTS, A LEAD IMPEDANCE, V LEAD MEASUREMENTS, % AV PACING DISTRIBUTION, WERE MISSING IN THE AIDA HOLTER MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2427

    Patients

    Seq Age Sex Outcome Treatment
    1