BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3965023 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13636
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 8, 2014
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V297034, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V210498, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD WALKING ISSUES OVER THE LAST 2 MONTHS PRIOR TO REPORT AND IT WAS A GRADUAL ONSET. THEY ALSO HAD A TREMOR IN THEIR LEFT LEG. THE PATIENT HAD TWO DEEP BRAIN STIMULATORS (DBS) AND THEY WERE TOLD THEY NEED TO GET ONE OF THE DBS IMPLANTS REPLACED. THE HEALTH CARE PROFESSIONAL (HCP) HAD RECOMMENDED GETTING THE LEFT DBS REPLACED FIRST SINCE THE PATIENT¿S INSURANCE WOULDN¿T PAY FOR BOTH OF THEM TO GET REPLACED. THE PATIENT¿S WALKING WAS GETTING BAD SO THEY WENT BACK IN TO GET THE DEVICE CHECKED. THE HCP THOUGHT ¿IT WAS BAD AND NOT ON TOTALLY¿ AND THE PATIENT HAD INQUIRED IF THEY COULD GET IT TURNED ON. THE PATIENT WAS ABLE TO USE THEIR PATIENT PROGRAMMER TO CHECK DEVICE STATUS AND THEY CONFIRMED ON BOTH SIDES, LEFT AND RIGHT, THAT THE PATIENT¿S THERAPY WAS ON WITH STATUS LIGHTS. THE PATIENT FELT TINGLING IN THEIR RIGHT HAND.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD TROUBLE WALKING AND BALANCE ISSUES FOR EIGHT MONTHS. THE PATIENT HAD SEEN THEIR HEALTHCARE PROFESSIONAL (HCP) FOR THIS ISSUE, BUT THEY DID NOT DO ANYTHING. THE PATIENT WANTED TO MEET WITH A MANUFACTURING REPRESENTATIVE TO BE REPROGRAMMED. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441131 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR