BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4520774 · Received February 17, 2015

    Report

    Report Number
    3004209178-2015-03099
    Event Type
    Malfunction
    Date Received
    February 17, 2015
    Report Date
    January 27, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3888-45, LOT# V760959, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V691320, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A POSSIBLE PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED SEEING THE ELECTIVE RE PLACEMENT INDICATOR (ERI) MESSAGE AND END OF SERVICE (EOS) MESSAGE. IT WAS EXPLAINED WHAT THIS MEANT. A FEW WEEKS AGO HE NOTICED IT STOPPED WORKING AND STOPPED FEELING THE SHOCKS AND HAD NO STIMULATION SENSATION. HE KNEW IT HADN¿T BEEN WORKING FOR AT LEAST A MONTH. IT WAS NOTED THE PATIENT HAD BEEN ON A 200 MILE AMBULANCE RIDE AND WENT TO THE HOSPITAL BUT THAT IT WASN¿T RELATED TO THE INS; IT WAS BECAUSE HE COULDN¿T DRIVE BECAUSE HE GOT HEAVIER IN WEIGHT. IT WAS NOTED HIS BACK MUSCLES WERE STRONGER AND HE WASN¿T USING THE INS. WHEN HE LOST SOME WEIGHT HE WAS IN PAIN HE WENT TO TURN IT ON AND THE BATTERY WAS EMPTY. HE REPORTED HE HADN¿T SEEN A DOCTOR IN 10 YEARS BECAUSE HE MUSCLED UP IN HIS BACK AND WAS DOING BETTER. HE USUALLY USED THE INS FOR 21 MONTHS ON A BATTERY. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WIL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112503 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1