BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2963056 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02689
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 26, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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# V603774, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V603774, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A TROUBLE WALKING SINCE IMPLANT, AND IT WAS LATER SAID THE PATIENT HAD HAD TROUBLE WITH TALKING SINCE 4-5 MONTHS AGO. THE PATIENT WAS AT HEALTHCARE PROFESSIONAL (HCP) OFFICE 2 WEEKS AGO AND HIS IMPLANT WAS ON AND OKAY AFTER HCP CHECKED IT. IT WAS STATED THAT THIS WEEK PATIENT'S WALKING AND TALKING WEREN'T VERY GOOD AND WHEN HE CHECKED HIS IMPLANT HE HAD TROUBLE WITH IT, BUT WAS ABLE TO CONFIRM THAT HIS IMPLANT WAS OFF AND HE TURNED IT BACK ON. IT WAS STATED THAT THE DEVICES MIGHT HAVE BEEN OFF FOR A FEW DAYS. THERE WAS A POSSIBILITY OF A SECURITY GATE TURNING HIS DEVICES ON/OFF IN THE PAST. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION WAS ALSO REPORTED ON PATIENT'S OTHER SIDE IMPLANT IN REGULATORY REPORT # 3004209178-2013-02688.

    Description of Event or Problem · 1

    IN ADDITION TO THE PREVIOUSLY REPORTED INFORMATION, IT WAS REPORTED, THE PATIENT WAS ¿FEELING REAL BAD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67083 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR