BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2801901 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-09444
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-60 LOT#, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 355028 LOT# N316557, IMPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE PATIENT EXPERIENCED A "PINS AND NEEDLES" OR "STABBING/ZAPPING" SENSATION WHILE STIMULATION WAS TURNED OFF. IT WAS UNKNOWN WHEN THE PATIENT'S SYMPTOMS STARTED. IT WAS NOTED, THE PATIENT HAD 18 INJECTIONS SINCE (B)(6) 2011. IT WAS REPORTED THE PATIENT HAD SCIATICA AND PINCHED NERVES. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 1.5 MONTHS LATER REPORTED, THE PATIENT'S STIMULATION HELPED HIS LOWER EXTREMITIES; HOWEVER, HE HAD PERSISTENT TENDERNESS AROUND THE STIMULATOR POCKET. IT WAS NOTED THERE WERE PLANS TO DO A REVISION/MOVE THE POCKET. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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