BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3253816 · Received July 30, 2013

    Report

    Report Number
    3004209178-2013-12472
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Report Date
    July 8, 2013
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V389407, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V389407, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS READING LOW OUT OF RANGE IMPEDANCE VALUES. PROGRAMMING HAD PREVIOUSLY BEEN CHANGED BECAUSE IT WAS CAUSING SOME SWEATING. THERAPY IMPEDANCE WAS FINE BUT 10/11 WAS SHOWING 54 OHMS. PATIENT HAD 8-9-10+11+ PROGRAMMED ON THEIR RIGHT LEAD. PATIENT WAS RECEIVING GOOD THERAPY. 0/2 WAS SHOWING 2295 OHMS AND 2039. PREVIOUS IMPEDANCES WERE NOT AVAILABLE TO COMPARE IF THIS LOW IMPEDANCE HAD BEEN THE CASE SINCE IMPLANT. THE HEALTH CARE PROVIDER CONFIRMED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT NOTICES BREAKTHROUGH TREMOR FAIRLY FREQUENTLY TO THE DAY, BUT IT WAS NOT PARTICULARLY DISABLING. HE DOES NOTICE HESITATION AND/OR FREEZING THAT CHANGES HIS BALANCE WHICH WAS NOT PRESENT EVERY DAY. HE HAS FLUCTUATING DAYTIME FATIGUE AND VITAMIN D DEFICIENCY. HE MAY NEED ADDITIONAL VITAMIN D SUPPLEMENTATION BEYOND HIS MULTIPLE VITAMIN. ADDITIONAL PROGRAMMING WITH HIS DEVICE WAS DONE ON (B)(6) 2013. THE BATTERY LEVEL WAS AT 2.84V. THE FINAL DEVICE SETTINGS PRODUCED BETTER TREMOR CONTROL WITHOUT SIDE EFFECTS. HE WAS GOING TO RETURN IN 4-6 WEEKS FOR ADDITIONAL PROGRAMMING IN A RELATIVE OFF STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356250 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1