BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3626347 · Received February 13, 2014

    Report

    Report Number
    3004209178-2014-02931
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V062134, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V080811, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WANTED TO KEEP HIS RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) OFF. THE PATIENT WAS WONDERING IF THERAPY WAS OFF IF THE YELLOW LIGHT WAS ON. HE WANTED TO TURN OFF HIS RIGHT SIDE, NOT THE OTHER SIDE. THE PATIENT WAS ASSISTED IN TURNING THE LEFT INS ON AND RIGHT INS OFF. IT WAS REPORTED FOR THE PAST YEAR THE PATIENT¿S DOCTOR HAD BEEN EXPLORING THE PATIENT¿S NECK FOR A SHORT IN THE WIRE. THE PATIENT SAW A NEUROSURGEON LAST WEEK (B)(6). THEY WERE GOING TO START PROCEDURE TESTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE. SEE MFR REPORT # 3004209178-2014-02930 FOR THE PATIENT'S LEFT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96591 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR