BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3853529 · Received June 6, 2014

    Report

    Report Number
    9614453-2014-01062
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 14, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND NO ANOMALY. THE INS WAS TESTED WITH A KNOWN GOOD LEAD. THE PROXIMAL END OF THE LEAD WAS CONNECTED TO THE INS, WHILE THE DISTAL END AND INS WERE SUBMERGED IN A 0.9% SALINE SOLUTION. USING A CLINICIAN PROGRAMMER, NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT ELECTRIC PULSES AT AN UNKNOWN LOCATION. TROUBLESHOOTING WAS SCHEDULED FOR (B)(6) 2014. IT WAS LATER REPORTED THAT ALL IMPEDANCES WERE OK DURING TROUBLESHOOTING, BOTH PRE-OPERATIVELY AND POST-OPERATIVELY AND THERE WAS NO ABNORMALITY IN THE EXTENSIONS. THE PATIENT WAS IMPLANTED WITH A NEW DEVICE AND WAS DOING OK. APPROXIMATELY A WEEK LATER, IT WAS REPORTED THAT THE ELECTRIC PULSES WERE NOT PRESENT WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS SWITCHED OFF. THE PULSES WERE SOMETIMES ¿PROVOKED¿ BY CERTAIN BODY POSTURES OR PALPATIONS SUCH AS WHEN THE PATIENT ¿DID THE ARM VERY STRONG TO THE BACK¿ AND OTHER TIMES WERE NOT. THERE HAD BEEN NO FALLS OR TRAUMA THAT COULD HAVE AFFECTED THE SYSTEM. THERE WERE NO ANOMALIES OBSERVED ON THE INS HEADER DURING EXPLANT.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331156 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention