BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3432622 · Received October 28, 2013

    Report

    Report Number
    3004209178-2013-19764
    Event Type
    Malfunction
    Date Received
    October 28, 2013
    Date of Event
    October 6, 2013
    Report Date
    October 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V210498, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40 LOT# V668795, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_PTM_PROG; PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS STIMULATOR WAS TURNED OFF AND WAS UNABLE TO BE TURNED BACK ON. THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS STATED THAT THE ¿CONTROLLER WAS NOT FUNCTIONING RIGHT.¿ THE ¿CONTROLLER¿ WOULD NOT ¿TURN HIM ON.¿ THE PATIENT HAD BEEN SEEN 2 WEEKS PRIOR AND WAS TOLD THAT THE INTERNAL BATTERY STILL HAD A COUPLE YEARS LEFT. THE PATIENT WAS ASSISTED TO TURN THE PROGRAMMER AND THEN BOTH STIMULATORS ON. IT WAS UNKNOWN HOW THE DEVICE GOT TURNED OFF AS THE PATIENT DOES NOT TURN IT OFF. THE POSSIBILITY OF ELECTROMAGNETIC INTERFERENCE WAS REVIEWED, BUT THE PATIENT WAS AT A CABIN. A ROUTER HAD JUST BEEN INSTALLED AND THE PATIENT WONDERED IF THAT COULD BE IT. THE CORRECT BATTERIES WERE BEING USED IN THE PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552342 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR