BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2834579 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10343
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STIMULATION WAS TURNED ON AND THE PATIENT WOULD PUT HER CHIN TO HER CHEST, LIKE A NODDING HEAD MOTION, THE STIMULATION THAT WAS DOWN HER LEG CUT OFF. IT WAS ALSO REPORTED THAT THE DEVICE HAD MOVED OVER CLOSER TO HER SPINE AND WAS RUBBING ON SOMETHING, PERHAPS A BONE, WHICH THE PATIENT BELIEVED OCCURRED OVER TIME AS SHE WAS ADVISED TO SLEEP ON HER RIGHT SIDE, BUT CANNOT DUE TO A NECK SURGERY THAT SHE HAD. THE STIMULATION DOES NOT RELIEVE THIS NEW PAIN, SHE HURT ALL DAY YESTERDAY, SLEPT AND WOKE UP WITHOUT PAIN, AND NOW STARTED TO HURT AGAIN. THE PATIENT HAD DONE A LOT OF THINGS AROUND THE HOUSE THAT MIGHT HAVE CONTRIBUTED, BUT NOT TODAY. THE PATIENT WAS GOING TO MAKE AN APPOINTMENT TO SEE HER PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT RECEIVED AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1