BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR

    MDR report key: 2951739 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00058
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 5, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, IT WAS NOTED THAT THERE WAS A SET SCREW MISSING AND A GROMMET WAS DAMAGED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN WAS NOT ABLE TO CONNECT THE LEAD TO THE DEVICE. THE DEVICE WAS NOT IMPLANTED AND ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57334 ADVISA DR NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1