BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3000396 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-03603
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 16, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 748295, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37092, LOT# 214180001, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 3387S-40, LOT# V055961, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V045101, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD ORIGINALLY NOTICED THAT BATTERY WAS DRAINED BECAUSE THE PATIENT¿S SYMPTOMS HAD INCREASED DRAMATICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS CHARGING MORE OFTEN THAN WAS EXPECTED. THE PATIENT USUALLY 'GETS A LOT MORE TIME BETWEEN RECHARGE SESSIONS.' THE PATIENT'S BATTERY WAS FULLY CHARGED AND BY THE NEXT NIGHT IT WAS 'DEAD.' IT WAS NOTED THAT THE PATIENT NEVER HAD THE BATTERY DIE IN 3 YEARS. THE PATIENT SAW THEIR HEALTH CARE PROVIDER (HCP) AND HAD THEIR DEVICE REPROGRAMMED. LATER THE SAME DAY IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST THE STIMULATION. THE PROGRAMMER INDICATED THAT THE BATTERY WAS LOW. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT HAD A 'SMALL' REPROGRAMMING ON (B)(6) 2013. TWO DAYS AFTER REPROGRAMMING THE BATTERY HAD DEPLETED. IT WAS CONFIRMED THAT THE RECHARGER WAS GETTING 'EXCELLENT' COUPLING, BETWEEN 6-8 BARS. THE NEXT DAY IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS FULLY CHARGED THE PREVIOUS NIGHT AND NOW IT IS AT HALF THE CHARGE CAPACITY. IT WAS STATED THAT THE PATIENT WAS RE-PROGRAMMED BY THEIR HCP THE PREVIOUS WEEK AND 2 DAYS AFTER RE-PROGRAMMING THAT BATTERY HAD DEPLETED. IT WAS STATED THAT THE HCP HAD BEEN 'TWEAKING' THE PATIENT'S PROGRAMMING. A DAY LATER IT WAS REPORTED THAT WHEN THE PATIENT WAS RE-PROGRAMMED, THE HCP ADDED ELECTRODE #0 TO BE PROGRAMMED AS 2+/1-/0-. THE HCP CHECKED THE IMPEDANCES AFTER REPROGRAMMING AND STATED THAT THEY WERE 'FINE.' THE PATIENT RETURNED TO THE DOCTOR'S OFFICE STATING THAT THE BATTERY WAS DYING MUCH MORE QUICKLY. THE IMPEDANCES WERE CHECKED AGAIN THERE WERE 'LOW OUT OF RANGE' IMPEDANCES BETWEEN ELECTRODES 2 AND 0, MEASURING 80 OHMS. FIVE DAYS LATER IT WAS REPORTED BY THE HCP THAT THE CAUSE OF THE EVENT WAS A SHORT CIRCUIT, 83 OHMS. THERE WAS NO PATIENT INJURY OR HOSPITALIZATION. THE PATIENT WAS RE-PROGRAMMED TO AVOID USING CONTACT 0. IT WAS NOTED THAT THE HCP WAS GOING TO DO AN X-RAY. ABOUT ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT HAD NO CONCERNS WITH THEIR DEVICE OR THERAPY. THEY HAD RECEIVED ASSISTANCE AND THEIR CONCERNS WERE RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104027 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1