BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3660629 · Received March 5, 2014

    Report

    Report Number
    3004209178-2014-03960
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Report Date
    February 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40, LOT# V020186, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V534087, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVER THE WEEKEND, THE PATIENT¿S IMPLANT GOT TURNED OFF, MOST LIKELY PATIENT WAS NEAR A MAGNET. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A PROGRAMMER SO THERE WAS NO WAY TO CHECK IT OR TURN IT BACK ON. IT WAS NOTED THAT THERE WAS STILL QUITE A BIT OF BATTERY LIFE SO THIS WAS NOT DUE TO BATTERY DEPLETION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS ABLE TO TURN THE BATTERY BACK ON. PLEASE REFER TO MANUFACTURER REPORT #3004209178-2014-03959 FOR THE PATIENT¿S OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133974 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR