BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4232825 · Received November 6, 2014

    Report

    Report Number
    9614453-2014-02588
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 7, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE DEVICE HAD REACHED ¿NORMAL END OF LIFE¿ WITH ¿NO TELEMETRY AND NO OUTPUT.¿

    Description of Event or Problem · 1

    THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN ¿UNABLE TO BE INTERROGATED WITH A PHYSICIAN PROGRAMMER OR PATIENT PROGRAMMER FOR SOME TIME¿ AT THE TIME OF REPORT. IT WAS UNKNOWN WHETHER THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE INS WAS REPLACED AS A RESULT OF THE EVENT. THE PATIENT¿S NEW INS WAS NOTED AS BEING ¿ABLE TO BE INTERROGATED¿ AND THE PATIENT WAS ¿RECEIVING THERAPY¿ WITH THE NEW INS. THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713939 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention