BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9614453-2013-00938

    MDR report key: 3050944 · Received April 10, 2013

    Report

    Report Number
    9614453-2013-00938
    Event Type
    Injury
    Date Received
    April 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POCKET INFECTION. ANTIBIOTICS WERE GIVEN, AND THE DEVICE WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149761 NVZ IPG MFG SWITZERLAND DTBA2D1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R