BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2834576 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10342
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 18, 2012
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V107750, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUSTAINED A "BAD FALL ON HIS HEAD" ON (B)(6) 2012. THE PATIENT'S "FOREHEAD IS ALL ABRAIDED AND HE HAD 40 STITCHES AROUND HIS EYE." THERE WAS A QUESTION AS TO WHETHER THE LEADS WERE DISLODGED BECAUSE OF THE FALL AS THE PATIENT WAS "VERY DIFFERENT ON HIS MOBILITY AND ALERTNESS AND STUFF," BUT IT WAS NOT BEING SAID THAT "IT WAS FROM THE BRAIN STIMULATOR." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD FREEZING EPISODES RELATED TO PARKINSON'S, WHICH CAUSED HIM TO FALL. IT WAS REPORTED THAT THERE WAS A KNOWN BREAK AFFECTING ELECTRODE 3 WITH AN IMPEDANCE MEASUREMENT OVER 2000. IT WAS NOTED THAT THIS BREAK OCCURRED AT THE TIME OF IMPLANTATION. IT WAS REPORTED THAT THE PATIENT WAS SEEN IN A DEEP BRAIN STIMULATION CLINIC IN VANCOUVER ON (B)(6) 2012. THE REPORTER STATED THAT THE PATIENT WAS CURRENTLY RECEIVING GOOD BENEFIT FROM THERAPY. IT WAS NOTED THAT CURRENTLY PROGRAMMING HAD NORMAL IMPEDANCES AND CURRENT DRAIN. THE REPORTER STATED THAT THERE WAS AN INCREASE IN PARKINSON'S SYMPTOMS TEMPORARILY AND AN INCREASE IN DYSKINESIAS. IT WAS NOTED THAT THE EVENT REQUIRED HOSPITALIZATION OF THE PATIENT, AND THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1