BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1915544 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08926
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WHILE STIMULATION WAS ON, THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION. THE SHOCKING/JOLTING SENSATION FELT TWO TIMES PER DAY, OVER HER ENTIRE RIGHT SIDE OF HER BODY. MOVEMENT, NOR PALPATION WOULD CAUSE STIMULATION CHANGES. THE SENSATION SEEMED TO BE RANDOM IN NATURE. THE PATIENT WAS STILL RECEIVING GOOD RELIEF IN REGARDS TO TREMOR. AN X-RAY REVEALED A KINK IN THE LEAD. A PHYSICIAN RECENTLY DETERMINED THAT THE DEVICE BATTERY HAD A VOLTAGE OF 3.25 VOLTS WHICH WAS BELOW THE LOW STATUS BY QUITE A BIT. LATER THE VOLTAGE WAS NOTED AT 3.72 VOLTS. IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS ON ALL COMBOS WITH 0 AND 1, HOWEVER, THOSE WERE NOT BEING USED FOR PROGRAMMING. A LONGEVITY CALCULATION ESTIMATED THAT THE DEVICE BATTERY LIFE TO BE 40 MONTHS AT 2.5 VOLTS, 180 US, 185 HZ, AND IF FUNCTIONING 24 HRS/DAY EVERYDAY. THE PT WAS SCHEDULED TO VISIT THEIR PHYSICIAN FOR F/U IN APPROX 2 WEEKS, TO CHECK ON THE STATUS OF THE SHOCKING AND HER THERAPY. ON (B)(6) 2010, IT WAS LATER REPORTED THAT THE PATIENT VISITED HER NEUROSURGEON ON (B)(6) 2010. UPON REVIEW OF THE PATIENT'S X-RAYS, IT WAS DETERMINED THAT A SURGICAL PROCEDURE WAS NECESSARY IN ORDER TO PERFORM INTRA-OPERATIVE IMPEDANCE TESTING TO FURTHER EVALUATE THE OPEN CIRCUIT. SURGERY WAS SCHEDULED FOR (B)(6) 2010. THE LEAD EXTENSION CONNECTION WAS PLANNED TO BE OPENED TO PERFORM THE IMPEDANCE TESTING. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR PROGRAMMER: MODEL 7438, LOT# NHL021350P| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU150100V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V014889| EXPLANTED: