BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2924669 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00809
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    August 5, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V494243, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V494243, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V494243, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN ON A HEART MONITOR A WEEK BEFORE CHRISTMAS AND INDICATED THEY WERE SHAKING WHILE THEY HAD THE MONITOR ON. IT WAS NOTED IT WENT AWAY WHEN THE DEVICE WAS TAKEN AWAY. THERE WAS TROUBLE GETTING A READING FROM THE HEART MONITOR SO THE PATIENT TURNED THEIR DEVICE OFF TO GET READINGS. IT WAS NOTED THE PATIENT WAS NOT SHAKING AT THE TIME OF REPORT AND THAT THE PATIENT HAD AN APPOINTMENT TO GET ADJUSTED. IT WAS ALSO NOTED THE PATIENT'S LEGS HAVE BEEN 'HEAVY' SINCE IMPLANT. THE PATIENT WAS ADJUSTED TWO MONTHS PRIOR AND IT RELIEVED THE HEAVINESS IN THEIR LEGS BUT APPROXIMATELY FOUR WEEKS PRIOR IT CAME BACK. 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 HAD A HISTORY OF FALSE ALARMS WITH HIS STIMULATION SYSTEM. IT WAS STATED THAT THE PATIENT "SAID THIS WERE WRONG IN ORDER TO GET ATTENTION". DURING THE LAST PROGRAMMING SESSION, THE PATIENT STATED HE NEEDED HELP, BUT THEN CANCELLED THE APPOINTMENT. IT WAS STATED THAT THERE HAD BEEN "SEVERAL" COMPLAINTS ABOUT THE PATIENT. IT WAS NOTED THAT "PSYCHOLOGICALLY" THERE WAS BELIEVED TO BE A PROBLEM. NO FURTHER INFORMATION WAS PROVIDED. REFER TO MANUFACTURER REPORT #3004209178-2013-00818. THE PATIENT HAS TWO DEVICES AND IT WAS UNCLEAR WITH DEVICE PERTAINED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31067 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1