BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1800918 · Received August 10, 2010

    Report

    Report Number
    1000165971-2010-00861
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 30, 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). 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 ASSOCIATED TO THE VENTRICULAR CHANNEL DURING AN IMPLANT ATTEMPT; THEREFORE, THE SUBJECT DEVICE WAS NOT IMPLANTED. REPORTED, THE LEAD COMPLETELY INSERTED INTO THE CHANNEL, THE SET-SCREW WAS TIGHTENED OBTAINING CLICKING OF THE SCREWDRIVER, BUT THEN THE LEAD COULD BE REMOVED BY PULLING. THIS WAS REPRODUCED ALSO WITH THE ATRIAL LEAD INSERTED INTO THE VENTRICULAR CHANNEL. THE PHYSICIAN HAS WATCHED THE LEAD CONNECTION VIDEO POSTED ON THE COMPANY WEBSITE, BUT IT IS NOT KNOWN, IF THE RECOMMENDATIONS WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2444

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention