BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2900096 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00248
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 14, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELT LIKE SHE WAS BEING SHOCKED AND IT "HIT ONCE" AND THEN "HIT REALLY HARD AGAIN." THE REPORTER STATED THAT THE SHOCKING WAS LOCATED UP TOWARDS THE SHOULDER BLADES WHERE THE LEAD WAS, MIDWAY UP THE BACK. IT WAS NOTED THAT THE SHOCKING STARTED ABOUT TWO WEEKS AGO AND ABOUT 3-4 TIMES A DAY. THE SHOCKING HAPPENED WHEN THE PATIENT WAS CLEANING HOUSE OR SITTING DOWN. IT WAS REPORTED THAT THE SHOCKING HAPPENED "ANYTIME" AND SOMETIMES FELT LIKE A SPASM. THE REPORTER STATED THAT THERE WAS NO FALL OR TRAUMA ASSOCIATED WITH THE EVENT BUT THE PATIENT STILL HAD A LOT OF BACK PAIN AND MEDICATION. IT WAS REPORTED THAT WHEN THE PATIENT TURNED ON THE STIMULATION IT HELPED HER LEGS AND A LITTLE BIT OF THE BACK. THE REPORTER STATED THAT THE THERAPY WAS SUPPOSED TO COVER BOTH OF HER LEGS, HER RIGHT/LEFT SIDES, AND THE MID PART OF THE BACK. IT WAS NOTED THAT THE PATIENT'S HEALTH CARE PROVIDER (HCP) ADJUSTED THE DEVICE ABOUT 1-2 MONTHS AGO. THE REPORTER STATED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT, AND WHEN THE PATIENT ADJUSTED THE DEVICE "TOO MUCH" HER LEGS STARTED SHAKING "REALLY, REALLY BADLY" AND WERE WOBBLY. THE DEVICE WAS ON GROUP E FOR THE BACK AND LEGS AT THE TIME OF THE REPORT AND THE PATIENT WENT BACK AND FORTH BETWEEN PROGRAMS "ALL THE TIME." THE REPORTER STATED THAT THE PATIENT FELT A BURNING SENSATION ON THE ENTIRE BACK "QUITE A BIT," SOMETIMES THREE TIMES A DAY AND SOMETIMES IT VARIED. IT WAS REPORTED THAT THE HCP DID AN X-RAY AND "COULD NOT DO ANYMORE" FOR THE PATIENT. THE REPORTER STATED THAT THE X-RAY FOUND "AN ISSUE" BUT THE HCP DID NOT WANT TO WORK ON OR OPERATE ON THE PATIENT'S BACK AND "NO MORE COULD BE DONE." IT WAS NOTED THAT THE PATIENT WAS GOING TO BE SEEING A PAIN MANAGEMENT HCP. 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
    8037 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1