BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 4243569 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21322
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V825993, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS NOT STAYING ON. THE ISSUE HAD BEGUN ON THE DATE OF THIS REPORT. THE PATIENT HAD TWO DEVICES IMPLANTED AND THE CURRENT ISSUE WAS WITH THE LEFT OLDER MODEL. THEY WERE CHECKING IT WITH THE PATIENT PROGRAMMER AND THE LIGHT WAS GREEN FOR THE 9 VOLT BATTERY BUT THERE WAS NO LIGHT NEXT TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY ICON. THE PATIENT COMPLAINED THAT THE DEEP BRAIN STIMULATOR WAS TURNING ON AND OFF. THE ACTION TAKEN TO RESOLVE THE ISSUE WAS THE PATIENT¿S HUSBAND CHANGED THE BATTERY. THE CAUSE OF THE EVENT WAS DETERMINED. THE PATIENT HAD RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726922 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR