BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3133827 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08309
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 3, 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 3387S-40, LOT# V062549, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3550-09, LOT# LC4456, IMPLANTED: (B)(6) 2004, PRODUCT TYPE ACCESSORY; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT# J0454231V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT LOW IMPEDANCES WERE SEEN ON ELECTRODE PAIR #4-6 (63 OHMS) AND THAT THE PATIENT WAS USING ELECTRODE PAIR #4-, 5+ (IMPEDANCE ON THAT PAIR = 501 OHMS). IMPEDANCE OF OTHER COMBINATION ELECTRODE PAIRS WERE AS FOLLOWS: #5 TO 7 = 1261 OHMS; #5 TO 6 = 497 OHMS; #6 TO 7 = 1027 OHMS; CASE TO #5 = 694 OHMS; CASE TO #4 = 541 OHMS, CASE TO #6 = 541 OHMS; CASE TO #7 = 1091 OHMS. IT WAS ALSO REPORTED THAT THE PATIENT WAS GETTING ¿FINE¿ THERAPY AT THIS TIME. LONGEVITY CALCULATIONS TO ESTIMATE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY LIFE WAS 14.9 MONTHS TOEND-OF-SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF EFFICACY (WHICH WAS STATED TO NOT BE RELATED TO STIMULATION THERAPY). THE PATIENT DID NOT HAVE A PROGRAMMER. THE PATIENT¿S TREMORS WERE MORE PREDOMINANT, WHICH STARTED A COUPLE OF MONTHS AGO. WHEN SEEN IN THE OFFICE, THE DEVICE WAS NOTED TO BE AT END OF LIFE (EOL). A LONGEVITY CALCULATION NOTED THE EARLY REPLACEMENT INDICATOR (ERI) TO BE AT 15.8 MONTHS AND EOL TO BE AT 18.8 MONTHS. THIS WAS NOTED TO BE NORMAL BASED ON THE PATIENT¿S SETTINGS. IMPEDANCES WERE FINE EXCEPT FOR ELECTRODE COMBINATION 4/6, WHICH WAS A SHORT AT 64 OHMS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SCHEDULED FOR A BATTERY CHANGE ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT HAD HER BATTERY REPLACED AS SCHEDULED. THE PATIENT HAD ANOTHER PRIMARY CELL DEVICE PLACED AND WAS DOING WELL. THE PREVIOUS SETTINGS WERE RESTARTED IN THE NEW STIMULATOR. THERE STILL REMAINED A SHORT BETWEEN ELECTRODE 4 AND 6. WHEN THE DEVICE WAS TURNED ON IN RECOVERY WITH THE PREVIOUS SETTINGS USED, A REDUCTION IN THE TREMORS WAS EVIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237118 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1