BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 1885334 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08363
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON THERE WAS A LOSS OF THERAPEUTIC EFFECT. THERE WAS A RAPID DECLINE IN SYMPTOM CONTROL OVER THE PAST FEW WEEKS. THE SYMPTOMS REPORTED WERE MUSCLE RIGIDITY AND GAIT CHANGES. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IMPEDANCE MEASUREMENTS WERE NORMAL IN DIFFERING BODY POSITIONS. THE PHYSICIAN PROGRAMMER REPORTED THERAPY "ON TIME" AS 0%, HOWEVER, CALLER REPORTED THAT THE DEVICE USAGE AND DIARY INFO INDICATED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN ON 100% OF THE TIME. CALLER REPORTED THAT SHE MADE A COUPLE OF CHANGES TO THE PROGRAMMED VOLTAGE, WENT BACK TO THE START SESSION SCREEN AND THE THERAPY "ON TIME" CHANGED TO 56%. CALLER REPORTED THAT THE INS WAS IN THE "ON" STATE WHEN SHE FIRST INTERROGATED IT AND ALSO THAT SHE DID NOT TURN INS ON OR OFF. CALLER REPORTED THAT PT DOES NOT OWN A PT PROGRAMMER AND THEREFORE DOES NOT HAVE THE ABILITY TO INADVERTENTLY TURN HIMSELF OFF. HCP INTERROGATED INS 3 TIMES. LAST INTERROGATION INS WAS THERAPY "ON"=0%, BUT DEVICE USAGE INDICATED INS USE FROM 8-12. THE BATTERY MEASUREMENT=2.92, REVIEWED THAT THIS SEEMS REASONABLE BASED ON IMPLANT DATE AND KNOWN BATTERY CHARACTERISTICS. CALLER REPORTED THAT ON THE RIGHT SIDE SHE INCREASED VOLTAGE UP TO 3.4 V AND DID GET SOME SIDE EFFECTS. ON THE LEFT SIDE SHE WENT UP TO 5.5V AND DID NOT GET ANY SIDE EFFECTS. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR EXPLANTED:| PROGRAMMER: MODEL 7436, LOT#: NFU010581P| LEAD: MODEL 3387S, LOT#: V018187| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT#: NHU132148V| EXPLANTED:| LEAD: MODEL 3387S, LOT#: V018187| EXTENSION: MODEL 7482, LOT#: NHU132145V| IMPLANTED: