BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2842893 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10678
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6) PRODUCT TYPE EXTENSION PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: 2004-(B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387-40, LOT# J0424862V, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3387-40, LOT# J0406018V, IMPLANTED: 2004-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP REPORTED THE PATIENT HAD RECEIVED ASSISTANCE FROM THEIR DOCTOR OR REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THERE WAS AN APPOINTMENT ON (B)(6) 2012. REFER TO MANUFACTURER REPORT # 3004209178-2012-10676. THE PATIENT HAD TWO IMPLANTABLE DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD TREMORS IN HIS HANDS THAT BEGAN THE DAY PRIOR TO THE REPORT. THE PATIENT STATED HE WENT TO A STORE ON (B)(6)-2012 AND WENT THROUGH A SECURITY GATE THAT "SOMETIMES" SHUT HIS STIMULATION OFF. IT WAS ALSO REPORTED THAT THE PATIENT'S PROGRAMMER WAS "NOT WORKING." THE PATIENT "JUST" CHANGED THE BATTERY AND A GREEN LIGHT WAS ON. THE PATIENT TRIED TURNING STIMULATION ON AND ONLY THE GREEN LIGHT CAME ON. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PLEASE SEE RELATED REPORT #3004209178-2012-10676. THE PATIENT HAD TWO IMPLANTABLE DEVICES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1