BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 2864827 · Received December 10, 2012

    Report

    Report Number
    9614453-2012-00253
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 9, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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 (A5DR01) 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: (B)(4): INITIALLY, THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED HIGH RESISTANCE/IMPEDANCE; SPECIFICALLY, HIGH BATTERY IMPEDANCE WAS NOTED WHICH LED TO THE EARLY RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS RETURNED AND ANALYZED. CALCULATIONS BASED ON IMPLANT PARAMETERS INDICATE THAT THE DEVICE HAD MET ITS 99.9% EXPECTED LONGEVITY. 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 INDICATED RECOMMENDED REPLACEMENT TIME (RRT) / ELECTIVE REPLACEMENT INDICATOR (ERI) WITHIN FOUR YEARS AND PREMATURE BATTERY DEPLETION WAS ALLEGED. 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
    1 ADVISA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A5DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R