BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 2952184 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00093
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 14, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S134
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND ANALYSIS OF THE DEVICE MEMORY FOUND THE ERI (ELECTIVE REPLACEMENT INDICATOR) IS THE RESULT OF HIGH INTERNAL BATTERY RESISTANCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) PREMATURELY. IT WAS NOTED THAT THE DEVICE ALSO TRIPPED RRT DUE TO DELTAV RAMWARE AND HIGH BATTERY IMPEDANCE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55561 ADVISA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A5DR01C

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R