BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KAPPA

    MDR report key: 3151684 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01090
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 4, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NORMAL BATTERY DEPLETION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT IS TIME FOR DEVICE REPLACEMENT. BATTERY VOLTAGE WAS 2.42 VOLTS, AND ELECTIVE REPLACEMENT INDICATOR (ERI) OCCURRED ON (B)(6)-2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED PREMATURE BATTERY DEPLETION. 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
    253180 KAPPA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND KDR703

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R