BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3624157 · Received February 12, 2014

    Report

    Report Number
    3004209178-2014-02862
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Report Date
    January 21, 2014
    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 MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# VA035YD, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V680690, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LOW OUT OF RANGE IMPEDANCE VALUES. IT WAS NOTED THAT 1 AND 2 MEASURED 29 OHMS. IMPEDANCES WERE C0=964, C1=720, C2=720, C3=1158, 01=982, 02=982, 03=1603, 12=29, 13=1090, AND 23=1084. PATIENT WAS PROGRAMMED AT 2-, 0+ AND THERAPY MEASUREMENT WAS 984 OHMS. IT WAS NOTED THAT WHEN PROGRAMMING EITHER ELECTRODE 1 OR 2 THEY WOULD BE RECRUITING THE OTHER RESPECTIVE ¿SHORTED¿ ELECTRODE. IT WAS FURTHER NOTED THAT THE PATIENT HAD FALLEN ABOUT 2 MONTHS PRIOR TO THIS REPORT. PATIENT HAD TREMOR MANAGEMENT ISSUES, IT WAS NOTED THAT THIS WAS ON-GOING AND NOT RELATED TO THE FALL. IT WAS NOTED THAT THEY HAD BEING ¿TRYING TO GET TREMOR UNDER CONTROL FOR QUITE A WHILE.¿ IT WAS UNKNOWN IF SURGICAL INTERVENTION WOULD BE REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92032 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Male