BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3402624 · Received October 10, 2013

    Report

    Report Number
    3004209178-2013-18781
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Report Date
    September 19, 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V925809, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V047362, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT HAD A BOWEL RESECTION ON THE DAY OF THIS REPORT AND HAD TURNED THE BILATERAL DEEP BRAIN STIMULATORS OFF PRIOR TO AND TURNED BACK ON POST PROCEDURE. PATIENT WAS HAVING SOME INTERMITTENT RETURN OF TREMOR AND WAS CONCERNED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT ON. IT WAS VERIFIED THAT BOTH DEVICES WERE ON. RIGHT SIDE WAS ON AND AT 2.90V WITH GROUP B AND THE LEFT SIDE WAS ON AT .8V WITH GROUP C. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURING REPORT NUMBER: 3004209178-2013-18780.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521106 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR