BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4012131 · Received August 15, 2014

    Report

    Report Number
    9614453-2014-02033
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 24, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND ¿THE DEVICE TO BE FULLY FUNCTIONAL WHEN POWERED BY EITHER THE INTERNAL BATTERY OR AN EXTERNAL SUPPLY. THE CLOCK OSCILLATOR FREQUENCY WAS FOUND TO BE NOMINAL. NEITHER THE REPORTED ¿POR DIAG¿ CORRUPTION NOR THE ¿CLOCK TOO SLOW" POR¿S WERE UNSUCCESSFULLY DUPLICATED. NO HYBRID ANOMALIES WERE FOUND.¿ IT WAS FOUND THE DEVICE HAD ¿INTERMITTENT POR OCCURRENCES¿ WITH AN ¿UNKNOWN¿ CAUSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE REPORTING MANUFACTURER REPRESENTATIVE WAS NOT AWARE OF ANY SOURCES OF ELECTROMAGNETIC INTERFERENCE (EMI) OR OTHER INTERFERENCE THAT MAY HAVE AFFECTED THE PATIENT OR DEVICE. IT WAS NOTED THE DEVICE WAS DELIVERED DIRECTLY FROM MANUFACTURER TO THE HOSPITAL AND WAS NOT KNOWN TO HAVE BEEN EXPOSED TO ANY DRAMATIC FLUCTUATIONS IN TEMPERATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT REQUIRED HOSPITALIZATION DUE TO POWER ON RESETS (PORS) THAT HAD OCCURRED WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS). AS A RESULT OF THE EVENT THE PATIENT EXPERIENCED ¿UPPER BODY TREMOR¿ AND ¿LESS THAT 50% THERAPY RELIEF.¿ THE ERROR CODE THAT ACCOMPANIED THE FIRST POR WAS UNKNOWN AT THE TIME OF INITIAL REPORT, HOWEVER, IT WAS NOTED THE POR WAS ¿SUCCESSFULLY CLEARED¿ AT THAT TIME. THE PATIENT¿S SECOND POR WAS NOTED TO HAVE BEEN A 0X2 ERROR CODE AND WAS NOTED TO HAVE BEEN ¿NOT SUCCESSFULLY CLEARED.¿ IMPEDANCE TESTING REVEALED THERE WERE ¿NO ELECTRODES OUT-OF-RANGE¿ AT THE TIME OF THE SECOND POR. AS OF SIX DAYS AFTER INITIAL REPORT, IT WAS NOTED THE PATIENT HAD EXPERIENCED A THIRD POR WHICH WAS NOTED TO AGAIN BE ACCOMPANIED BY A 0X2 ERROR CODE. THE PATIENT REPORTED THAT AT THE TIME OF HER THIRD POR ¿HER STIMULATION STOPPED.¿ THE PATIENT WAS SCHEDULED TO HAVE THEIR INS EXPLANTED AS OF 13 DAYS AFTER INITIAL 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
    491212 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R