BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2676226 · Received July 31, 2012

    Report

    Report Number
    3004209178-2012-06301
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Report Date
    July 3, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 377745, LOT#: V013307, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 377745, LOT#: V012663, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD; PRODUCT ID: 37752, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER; PRODUCT ID: 37742, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT HAD ACUTE PAIN IN HIS BACK; THE SYMPTOMS BEGAN AFTER AN 8 LEVEL SPINE FUSION DONE IN 2011. THE PATIENT HAD CAUDA EQUINA AND WENT TO HIS PHYSICIAN TO HAVE A SPINAL INJECTION AT THE END OF (B)(6) 2011. WHEN THE PATIENT ARRIVED AT HIS PHYSICIAN'S WORKPLACE, THE PHYSICIAN DETERMINED THAT FOLLOWING A FLUOROSCOPIC PROCEDURE, THE PATIENT WAS TO HAVE A BACK FUSION INSTEAD OF INJECTIONS. IT BEGAN AS A 4 LEVEL BACK FUSION. AFTER SURGERY, THE PATIENT WAS FITTED FOR A BRACE AND ENDED UP FRACTURING "HIS THORACIC." AFTER THAT, IT ENDED UP BEING AN 8 LEVEL BACK FUSION. THE PATIENT'S PROCEDURES OCCURRED BETWEEN (B)(6) 2011. THE PATIENT'S THERAPY HAS NOT WORKED SINCE THIS TIME AND HAS NOT HAD HIS STIMULATION ON FOR THE PAST YEAR. THE PATIENT STILL HAD PAIN IN HIS BACK AND AN ELECTRICAL TINGLING SENSATION UP AND DOWN HIS ARMS. THE PATIENT'S SYMPTOMS WERE THOSE OF THE SAME HE WAS EXPERIENCING BEFORE HIS DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT WAS WORKING WITH A MANUFACTURER REPRESENTATIVE AND THAT SHE WANTED TO TEST HIS DEVICE TO CONFIRM THAT HIS LEADS WERE INTACT BEFORE THE PATIENT UNDERWENT AN MRI PROCEDURE. THE PATIENT'S THERAPY WAS SUCCESSFUL FOR THE FIRST 5 YEARS AND "HE WAS VERY HAPPY WITH IT." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HIS DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1