BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2230520 · Received August 12, 2011

    Report

    Report Number
    1000165971-2011-00287
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 23, 2011
    Report Date
    July 19, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE OF THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED A CONNECTION ISSUE RELATIVE TO THE SUBJECT DEVICE. THE PHYSICIAN ALSO REPORTED THAT "DURING THE MAGNET TEST, THE PM DID NOT PACE WITH THE PROGRAMMER, THE IMPEDANCE DISPLAYED WAS 3000 OHMS." ANOTHER PACEMAKER WAS 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 2501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention