BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3864172 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01473
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 21, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    PRODUCT TYPE ACCESSORY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO SIGNIFICANT ANOMALIES. THE BATTERY WAS AT NORMAL END OF LIFE. TELEMETRY AND OUTPUT WERE OKAY. ANALYSIS OF THE BOOT FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DEPLETED PREMATURELY. THE PATIENT HAD BEEN PROGRAMMED TO .3V, 60'S, 185 HZ ON C+,2-,3- AND 3.8V, 90'S, 185 HZ ON C+,7-,6-, WITH IMPEDANCES OF 850HMS AND 1200 OHMS ON THE LEFT AND RIGHT SIDES RESPECTIVELY. THE DEVICE WAS SUBSEQUENTLY REPLACED. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. WINGEVITY CALCULATIONS PERFORMED WITH THE SETTINGS SPECIFIC TO THE RIGHT SIDE ESTIMATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) WOULD OCCUR AT 2.29 YEARS AND END-OF-SERVICE (EOS) AT 2.54 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338061 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention