BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3172892 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10447
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37651, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V020186, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V043903, IMPLANTED: (B)(6) 2007,PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DBS SYSTEM WAS "MISFIRING". IT WAS LATER REPORTED THAT THE PATIENT HAD A FALL ABOUT A MONTH AGO AND SEVERAL WEEKS LATER HAD DISC SURGERY IN HER NECK. IT WAS NOTED THAT THERE WERE NO CHANGES IN THERAPY BEFORE THE DISC SURGERY. FOLLOWING THE SURGERY THE PATIENT EXPERIENCED A SEVERE SHOCKING OR JOLTING SENSATION THAT TRAVELLED FROM THE INS POCKET UP THE NECK AND DOWN THE PATIENT'S ARMS. THE SENSATION WOULDN'T GO AWAY WITH STIMULATION ON OR OFF, THOUGH IT EVENTUALLY DID GO AWAY. IT WAS UNKNOWN IF THE INS WAS TURNED OFF FOR THE SURGERY, HOWEVER THE PATIENT HAD NOT TURNED THE INS ON SINCE THE SHOCKING SENSATION. IT WAS NOTED THAT IMPEDANCES WERE BETWEEN 1,200-4 ,000 OHMS, WHICH WAS WITHIN NORMAL LIMITS. IT WAS REPORTED THAT THE HCP WAS CONSIDERING REMOVING THE INS AND THE PATIENT WAS COMING INTO THE OFFICE NEXT WEEK. IT WAS LATER REPORTED THAT THE SHOCKING WAS DETERMINED TO BE RADICULOPATHY DUE TO INFLAMMATION RELATED TO THE SURGERY. THE PATIENT¿S DEVICE WAS TURNED BACK ON (B)(6), 2013 AND IT WAS REPORTED THAT THE ISSUE HAD NOT RETURNED AND THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REPORTED THAT IMPEDANCE CHECK WAS DONE AND THERE WERE SOME ¿OUT-OF-RANGE RESULTS.¿ IT WAS NOTED THAT ON THE LEFT SUBTHALMIC NUCLEUS, THERE WERE FOUR ¿THAT ARE OUT OF RANGE.¿ THE IMPEDANCES WERE TAKEN AT 0.7 VOLTS. IT WAS LATER REPORTED THAT THE IMPEDANCE CHECK SHOWED SLIGHTLY HIGH VALUES FOR SOME ELECTRODE COMBINATIONS BUT ¿NOTHING INDICATE AN OPEN CIRCUIT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274147 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR