BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2955067 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02506
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 23, 2013
    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) 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 THE PATIENT WAS ADMITTED TO THE HOSPITAL 3 TIMES IN ONE MONTH BECAUSE OF HER DEVICE; HER LEG WAS SWOLLEN AND SHE COULDN'T WALK. THE REPORTER INDICATED THAT THE PATIENT'S DEVICE "TRIGGERED ON AND ON" BUT WAS OFF AT THE TIME OF THE REPORT. IT WAS STATED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THE DEVICE HAD NEVER HELPED, ONLY ON THE DAY IT WAS IMPLANTED. THE PATIENT HAD CONSTANT PAIN ALL OVER; IN HER FEET, LEG, THIGHS, BACK, ARMS, AND HANDS. THE REPORTER STATED THAT THE PATIENT¿S SKIN HAD BEEN PEELING FOLLOWING IMPLANT. APPROXIMATELY 2 WEEKS LATER, IT WAS ADDITIONALLY REPORTED THAT THE PATIENT EXPERIENCED "VIBRATIONS" THROUGHOUT HER ENTIRE BODY, WHICH HAPPENED WHEN THE DEVICE WAS OFF. THE REPORTER INDICATED THAT THE PATIENT HAD TRIGEMINAL NEURALGIA AND WAS DELUSIONAL. THE PATIENT HAD A HISTORY OF FALLING, AND WAS NOTED TO HAVE FALLEN 2 WEEKS AFTER IMPLANT. THE PATIENT'S HEALTHCARE PROVIDER (HCP) DETERMINED THE FALLING WAS RELATED TO TRILEPTOL, WHICH THE PATIENT WAS TAKING FOR FIBROMYALGIA. THE REPORTER STATED THAT THE PATIENT WAS "VEGETABLE-LIKE", COULD NOT MOVE, HAD OSTEOARTHRITIS, AND ALSO HAD BLISTERS, SORES AND SWELLING. THE PATIENT WANTED HER DEVICE EXPLANTED AND WANTED A "DECENT LAST PART OF LIFE." IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59199 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization