BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3250596 · Received July 26, 2013

    Report

    Report Number
    3004209178-2013-12373
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# J0208359V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0209742V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FEELING FUNNY THAT ¿SOMETHING AIN¿T RIGHT¿ THE WEEK PRIOR TO THE DATE OF THIS REPORT. IT HAD BEEN GETTING WORSE COUPLE DAYS PRIOR TO THE DATE OF THIS REPORT. IT WAS REPORTED THAT THE DEVICE WAS TURNED OFF. IT WAS UNCLEAR WHICH DEVICE WAS TURNED OFF AND WHAT CAUSED IT. IT WAS NOTED THAT THE PATIENT¿S WIFE ¿ENDED UP TURNING IT OFF.¿ THE PATIENT USED THE MAGNET AND TURNED THE DEVICE BACK ON ON THE DATE OF THIS REPORT. THE DEVICE ON THE RIGHT SIDE WAS FOUND TO BE ¿OFF¿ LATER. THE PATIENT FELT TINGLING ON HIS LEFT SIDE OF HIS FACE AND HIS MOUTH WHEN THE DEVICE WAS INITIALLY TURNED ON. THE TINGLING SUBSIDED. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN REPROGRAMMED IN QUITE SOME TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350573 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR