BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3851712 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10200
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 19, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7438, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V616865, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V616865, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PAST 2-3 MONTHS PRIOR TO THE DATE OF THIS REPORT THE PATIENT HAD BEEN HAVING PAIN AT THE LEAD LOCATION. PATIENT SYMPTOMS WERE AT THE LEAD/EXTENSION LOCATION. IT WAS NOTED THAT THERE MIGHT BE SOME DIFFICULTY WITH THE LEADS. IT WAS NOTED THAT IT DID NOT SEEM TO BE FUNCTIONING PROPERLY. THE PATIENT WAS HAVING CONSTANT PAIN WHERE THE LEADS WERE THAT TRAVEL ON TOP OF HEAD ON BOTH SIDES. PATIENT HAD THE IMPLANT FOR PARKINSON¿S AND SYMPTOMS WERE ON AND OFF; WENT FROM ONE EXTREME TO ANOTHER. IT WAS NOTED THAT SOMETIMES IT WAS ON AND SOMETIMES IT WAS OFF AS FAR AS THE PAIN. THE PATIENT FELT ELECTRICITY GOING THROUGH THEIR HEAD. AN ADJUSTMENT WAS MADE BUT THEY WERE STILL HAVING IT. PATIENT HAD NO PROBLEMS IN THE BEGINNING. PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-10198.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329409 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR