BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2812054 · Received October 31, 2012

    Report

    Report Number
    6000094-2012-02399
    Event Type
    Injury
    Date Received
    October 31, 2012
    Report Date
    January 15, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLY. THE EARLY DEPLETION WAS SUSPECTED TO BE CAUSED BY CHRONIC LEAD INSULATION LOSS, HOWEVER, FOLLOW UP COULD NOT DETERMINE THE MANUFACTURER OF THE LEAD OR FURTHER DETAILS ABOUT THE LEAD. 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 N/A PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SES01

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R