BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3201017 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11166
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389-40, LOT# J0306910V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID NEU_PTM_PROG, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ¿NOT DOING VERY WELL¿ ALL OF A SUDDEN. THE PATIENT COULD NOT WALK, OR MOVE VERY WELL, THEY COULDN¿T TALK OR STAND UP AND GET OUT OF BED. THE REPORTER NOTED THE ¿BATTERY WENT DOWN.¿ IT WAS NOTED THE LAST TIME THE STIMULATOR WAS CHECKED WAS BACK IN 2010. FOLLOW UP REPORTED THE ¿DIAGNOSTICS WERE FINE.¿IT WAS NOTED THE ¿BATTERIES WERE ALMOST DEAD.¿ THE PATIENT WAS IN THE PROCESS OF GETTING SCHEDULED FOR REPLACEMENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS DOING "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303140 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR