BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3624166 · Received February 12, 2014

    Report

    Report Number
    3004209178-2014-02863
    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: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3387S-40, LOT# VA035YD, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 748351, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V680690, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD.

    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. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-02862.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92034 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Male