BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3140291 · Received May 31, 2013

    Report

    Report Number
    3004209178-2013-08475
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Report Date
    May 13, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# VA02PXP, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# VA02PXP, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO CORRECT CONCLUSION CODES.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND TREMORS ON THE LEFT SIDE, MOSTLY IN HIS HANDS, WHICH STARTED LAST WEEK. HE WAS NOT ABLE TO ADJUST STIMULATION. HE HAD A FALL ON (B)(6) 2013 AND BUMPED HIS HEAD. HE THOUGHT EVERYTHING WAS FINE BUT THEN NOTICED THE ¿CALL YOU DOCTOR¿ AND OUT OF REGULATION (OOR) ICONS THAT DISPLAYED ON THE PATIENT PROGRAMMER ON (B)(6) 2013. HE HAS BEEN UNABLE TO INCREASE STIMULATION SINCE THE FALL. HE WAS ABLE TO BYPASS THE OOR MESSAGE AND GET BACK TO THE HOME SCREEN BY HITTING THE NAVIGATOR KEY. IT WAS CONFIRMED THAT HIS STIMULATION WAS CURRENTLY ON. IT WAS NOTED THAT HE HAD HIS DEVICE REPROGRAMMED 3 WEEKS AGO. IMPEDANCE MEASUREMENTS WERE DONE. THE RIGHT SIDE WAS PROGRAMMED AT 2.5V, 60US, 180HZ, C+, 8-: C,8 1154OHMS; C,9 3816OHMS; C,10 1128OHMS; C,11 1262OHMS; 8,9 4171OHMS; 8,10 1821OHMS; 8,11 2104OHMS; 9,10 3923OHMS; 9 ,11 4754OHMS; 10,11 1577OHMS. IT WAS UNKNOWN WHY ELECTRODE 9 HAD HIGHER IMPEDANCES. THE LEFT SIDE WAS PROGRAMMED AT 4.1V, 90US, 180HZ, 1-3+: C,0 1087OHMS; C,1 1284OHMS; C,2 1051OHMS; C,3 1670OHMS; 0,1 1547OHMS; 0,2 1686OHMS; 0,3 2264OHMS; 1,2 1681OHMS; 1,3 2407OHMS; 2,3 1921OHMS. THE IMPEDANCES WERE NORMAL ON THE LEFT SIDE. THE PATIENT TURNS THE DEVICE DOWN TO 2.0V BUT IN THE MORNING HE TRIED TO TURN THE DEVICE UP TO 2.5V AND HE RECEIVED THE OOR MESSAGE. HE SAW HIS HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013 FOR REPROGRAMMING TO RESOLVE THE OOR MESSAGE WHICH WAS SUCCESSFUL. THOUGH 5 MINUTES OUT OF THE HCP¿S OFFICE THE DEVICE REVERTED TO IT¿S ORIGINAL PROBLEM. IT WAS CONFIRMED THAT THE PATIENT WAS STILL RECEIVING THERAPY AND NO INTERVENTION WAS NEEDED. THE ACTIVE CONTACTS WERE NOT IMPACTED. THE PATIENT NEEDED A LITTLE MORE VOLTAGE FOR HIS LEFT SIDE OF HIS BODY. THE LEFT SIDED IMPEDANCES REMAINED WITHIN NORMAL LIMITS. THE IMPEDANCES FOR THE RIGHT SIDE WERE HIGH: C,8 7796OHMS; C,9 3756OHMS; C,10 1163OHMS, C,11 1348OHMS; 8,9 9146OHMS; 8,10 5936OHMS; 8,11 6704OHMS; 9,10 4378OHMS; 9,11 5090OHMS;10,11 1705OHMS. HE WAS PROGRAMMED TO C+, 8-. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPROGRAMMED USING A CONTACT WHICH DID NOT HAVE IMPEDANCE ISSUES. THE PATIENT WAS RECEIVING ADEQUATE STIMULATION RESPONSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ELECTRODE 8 AND 9 HAD >4000 OHMS IMPEDANCE READING. THE UNIPOLAR IMPEDANCES WERE IN THE 7000 RANGE. THE PATIENT WAS CURRENTLY PROGRAMMED TO C+ AND 8-. THE THERAPY IMPEDANCE MEASUREMENT WAS 1061. IT WAS NOTED THAT "THEY WERE LOOKING TO PROGRAM 8 AND 9 DIRECTLY DUE TO THE CURRENT AMPLITUDE WAS 4.9 V IN THE SUBTHALMIC NUCLEUS AND WANTED TO REDUCE." IT WAS ADDED THAT THE FALL OCCURRED IN (B)(6) 2013 (AS REPORTED PREVIOUSLY) "MAY ACCOUNT FOR THE HIGHER THAN NORMAL IMPEDANCES." THE OUT OF REGULATION CONDITION THAT WAS REPORTED PREVIOUSLY WAS NO LONGER AN ISSUE AND THE PATIENT WAS GETTING THERAPY BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241734 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR