BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2685897 · Received August 7, 2012

    Report

    Report Number
    3004209178-2012-06590
    Event Type
    Malfunction
    Date Received
    August 7, 2012
    Report Date
    July 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37642, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID: 37092, LOT#: 321210001, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY; PRODUCT ID: 37085-40, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID: 37085-40, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT#: V951526, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT#: V951526, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT TURNED HER STIMULATION OFF FOR THE NIGHT; WHEN SHE TURNED IT BACK ON IN THE MORNING, SHE GOT A SHOCKING SENSATION. THE PATIENT WAS TYPICALLY AT AN AMPLITUDE OF 3.5 VOLTS FOR THERAPY. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS SHUT OFF AND TURNED DOWN TO 2 VOLTS BEFORE IT WAS TURNED BACK ON DURING A CLINIC VISIT ON (B)(6) 2012 USING THE PHYSICIAN'S PROGRAMMER (8840). IT WAS LEFT AT 2 VOLTS FOR THE REST OF THE DAY. BEFORE GOING TO SLEEP, THE PATIENT SHUT HER INS OFF AGAIN USING HER PATIENT PROGRAMMER (PP). AFTER SHE AWOKE AND TURNED IT ON AGAIN, IT RETURNED TO 3.5 VOLTS (AS READ BY HER PP), EVEN THOUGH SHE REMEMBERED IT BEING AT 2 VOLTS. THE PATIENT CONFIRMED THAT SHE HAD NOT INCREASED THE VOLTAGE HERSELF. NORMAL IMPEDANCES WERE MEASURED. THE PATIENT WAS TOLD TO LEAVE THE STIMULATION ON ALL OF THE TIME IF NEEDED AND NOT TO TURN IT DOWN AND OFF AT NIGHT AGAIN. IT WAS PLANNED THAT THE PATIENT WAS TO SEE HER PHYSICIAN AGAIN A MONTH FROM THE REPORT DATE TO CHECK ON HER SYSTEM. ADDITIONAL INFORMATION 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 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1