BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2843590 · Received November 23, 2012

    Report

    Report Number
    3004209178-2012-10706
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Report Date
    October 25, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NO LONGER HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED AN OVER STIMULATION SENSATION WHILE THE DEVICE WAS TURNED ON. IT WAS NOTED THAT THE PATIENT HAD SET HIS STIMULATION EARLIER IN THE DAY. HE THEN WENT OUT TO TAKE HIS DOG FOR A WALK AND HIS BACK BEGAN TO HURT SO HE WENT TO LAY DOWN. IT WAS REPORTED THAT WHILE THE PATIENT WAS LYING DOWN HE FELT OVERSTIMULATED AND WAS NOT ABLE TO DECREASE THE STIMULATION. IT WAS NOTED THAT THIS WAS THE FIRST TIME THAT THIS HAD HAPPENED TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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