BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4095617 · Received September 17, 2014

    Report

    Report Number
    9614453-2014-02062
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    EVALUATION OF INS MODEL 37601 SN (B)(4) FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETING SURGERY, IMPEDANCE TESTING SHOWED IMPEDANCES >40000 OHMS ON ALL LEFT SIDE ELECTRODE PAIRS EXCEPT C/0. IMPEDANCES ON THE RIGHT SIDE WERE WITHIN NORMAL LIMITS. THE CONNECTIONS WERE CHECKED AND FOUND TO BE OK. X-RAYS WERE PERFORMED AND NO ISSUES WERE SEEN WITH THE LEADS, EXTENSIONS, OR TRAJECTORIES. IT WAS NOTED THAT THE EXTENSIONS WERE ALSO TESTED PREOPERATIVELY. THE EXTENSIONS WERE TESTED WITH AN EXTERNAL NEUROSTIMULATOR (ENS) AND WERE GOOD. THE EXTENSIONS WERE AGAIN CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT HIGH IMPEDANCES WERE AGAIN OBSERVED. LOW IMPEDANCES WERE ALSO SEEN ON ONE CONTACT (32 OHMS). THE TESTING WAS REPEATED THREE TIMES. THE CONNECTIONS TO THE INS WERE REDONE AND THE PATIENT WAS REPOSITIONED, BUT THE ISSUES WERE NOT RESOLVED. IT WAS NOTED THAT WHEN THE NEUROSURGEON ATTEMPTED TO REMOVE THE EXTENSION FROM THE INS, IT WAS STUCK EVEN THOUGH THE SET SCREW WAS FULLY OPENED. THE NEUROSURGEON ¿COULD NOT REMOVE THE EXTENSION LIKE HE DID NORMALLY.¿ A NEW INS WAS USED, AND IMPEDANCE MEASUREMENTS WERE NORMAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT AND THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575993 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention