BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3513063 · Received December 10, 2013

    Report

    Report Number
    3004209178-2013-23344
    Event Type
    Injury
    Date Received
    December 10, 2013
    Date of Event
    November 14, 2013
    Report Date
    November 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387-40, LOT# V001976, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND BROKE THEIR SHOULDER ¿FROM THE TOP OF THEIR HUMERUS¿ THE THURSDAY PRIOR TO REPORT. THE MANUFACTURING REPRESENTATIVE INQUIRED IF THE FALL WAS RELATED TO THE IMPLANTABLE NEUROSTIMULATOR THERAPY AND THE PATIENT STATED NO AND THEY FELL BECAUSE OF THEIR ¿FREEZING.¿ IT WAS NOTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT THOUGHT THE INS WAS TURNED OFF BECAUSE THEY WERE SHAKING A LOT. THE PATIENT STATED THE THERAPY MAY HAVE BEEN TURNED OFF BY MAGNETS WORN BY THE TECHNICIANS AND AIDS AT A REHABILITATION FACILITY. THE PATIENT REPORTED SHAKING IN THEIR RIGHT FOOT AND LEFT HAND WHICH STARTED ¿A LITTLE BIT¿ THE MONDAY PRIOR TO REPORT AND GOT INCREASINGLY WORSE THE NIGHT PRIOR TO REPORT. IT WAS CONFIRMED THAT BOTH SIDES WERE TURNED OFF AND THE PATIENT WAS ABLE TO TURN THEM BOTH BACK ON. WHEN THE PATIENT INITIALLY TURNED THE INS ON THEY STATED ¿I CAN FEEL THE ELECTRICITY GO THROUGH ME.¿ THE MANUFACTURING REPRESENTATIVE INQUIRED IF IT WAS UNCOMFORTABLE AND THE PATIENT REPLIED ¿A LITTLE BIT.¿ THE PATIENT THEN STATED THAT THIS FEELING SUBSIDED AND THEIR SHAKING ALSO SUBSIDED. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643780 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention