BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2601830 · Received June 6, 2012

    Report

    Report Number
    3004209178-2012-04111
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Report Date
    May 8, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37085-60, LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 37085-60, LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3387, LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT THAT HAD ONE LEAD IN THE VIM WAS EXPERIENCING STRONG PARESTHESIA (JOLTING) IN ARM AND AT THE TIP OF THE HAND WHEN SET AT 0.5 VOLTS IN UNIPOLAR MODE AT EACH CONTACT/ELECTRODE. WHEN BIPOLAR CONTACTS WERE TESTED AT 6.5 VOLTS, THERE WAS NO RESPONSE OR PARESTHESIA. THE PATIENT DID NOT RECEIVE ANY THERAPY OR TREMOR CONTROL. CURRENT IMPEDANCE MEASUREMENTS WERE NOT NORMAL: C0 1254 OHMS, C1 1260, C2 1260, C3 2141, 01 33, 02 33, 03 3054, 12 34, 13 3054, 23 6054. THE PATIENT WAS PROGRAMMED TO 3-, 2+, 1- 1.5V, 60HZ, 230US. NO CHANGES WHERE OBSERVED WHEN THE PATIENT MOVED THEIR HEAD. ADDITIONAL INFORMATION REPORTED THAT 2 CONTACT PAIRS SHOWED LOW IMPEDANCE READINGS AND ONE PAIR SHOWED A HIGH IMPEDANCE READING. THE PATIENT WAS REPROGRAMMED AND SETTINGS WERE FOUND THAT OFFERED SYMPTOM RELIEF. THE PATIENT WAS PLEASED WHEN HE LEFT THE CLINIC.

    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