BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2644149 · Received July 6, 2012

    Report

    Report Number
    3004209178-2012-05308
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Report Date
    June 7, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V241399, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_UNKNOWN_PROG LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT'S STIMULATION WAS TURNING OFF. IT WAS NOTED THAT THE PATIENT CHECKED THE DEVICE THEY WERE NOT GETTING ANYTHING BESIDES 9 VOLT LIGHT. IT WAS FURTHER NOTED THAT THE 9 VOLT BATTERY HAD NOT BEEN REPLACED FOR A YEAR AND IT "DID NOT PASS THE SELF-TEST." THE PATIENT WAS ABLE TO TURN THE RIGHT STIMULATOR ON, BUT NOT THE LEFT. THE PATIENT'S WIFE STATED THAT SINCE (B)(6) 2012, THE PATIENT HAD NOT BEEN DOING "AS WELL." IT WAS NOTED THAT THE PATIENT HAD A SCHEDULED APPOINTMENT IN A FEW WEEKS. APPROXIMATELY 2 WEEKS LATER, THE PATIENT WAS UNABLE TO TURN HIS DEVICE ON WITH HIS PATIENT PROGRAMMER. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AND THE DEVICE WAS ON AND WORKING

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S THERAPY FELT LIKE THE STIMULATION WAS NOT WORKING THE SAME WAY THAT IT WAS THE WEEK PRIOR. STIMULATION WAS CHECKED AND IT WAS FOUND THAT THE LEFT SIDE "STIM" WAS OFF. IT WAS UNKNOWN HOW THE "STIM" HAD BEEN TURNED OFF. FURTHER FOLLOW-UP INDICATED THAT THE PATIENT HAD SOUGHT FURTHER HELP WITH THEIR DEVICE OR THERAPY, BUT STILL HAD CONCERNS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1