BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3011246 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03922
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Report Date
    March 8, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-41, LOT # N172225, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE PATIENT DESIRED TO HAVE THE INS REMOVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED ACUTE PAIN AND THAT THEIR INS HAD "IT MOVED UP OUT OF THE POCKET UPWARDS" TOWARDS THEIR BUTTOCKS AREA. IT WAS NOTED THAT THE PATIENT AVOIDED WEARING LOW RISE JEANS, BELTS AND LEANING UP AGAINST THINGS AS IT CAUSED THEM PAIN AT THE POCKET SITE. THE PATIENT NOTICED THIS ABOUT ONE TO ONE AND A HALF MONTHS AGO. THE PATIENT DID STATE THAT THEY HAD GAINED SOME WEIGHT RECENTLY SO THEIR POCKET SITE "IS NOT AS PAPER THIN AS IT WAS." IN ADDITION, THE PATIENT REPORTED CHARGING MORE THAN EXPECTED AND THAT THEY HAD NOT RECHARGED IN OVER A YEAR. IT WAS NOTED THAT IT WOULD TAKE A LONG TIME TO RECHARGE THE INS ("IT WOULD TAKE ME ALL DAY LONG"). THEY STATED THAT A HALF HOUR WOULD GO BY AND THE DEVICE WOULD DISPLAY THE LOW BATTERY AGAIN. THE PATIENT STATED THAT THEY HAVE HAD THE DEVICE TURNED OFF SINCE THAT TIME. IT WAS REPORTED THAT EVEN THOUGH THE PATIENT'S DEVICE WAS TURNED OFF FOR ABOUT A YEAR AND A HALF THEY SOMETIMES EXPERIENCED "HAVING A FEELING LIKE IT IS ON BUT IT'S OFF, EVERY NOW AND THEN I GET TWITCHES OR FEEL A TINGLING ON MY SPINE WHERE THE LEADS ARE LIKE A CURRENT THAT IT'S ON." IT WAS NOTED THAT THE PATIENT HAD "CLONKED" HERSELF A FEW TIMES BUT HAD NO FURTHER COMMENT ON THIS ISSUE. THE PATIENT HAD MET WITH THE MANUFACTURER'S REPRESENTATIVE A COUPLE OF TIMES TO "CHANGE THE RANGES" AND THEY STATED "IT DOES FEEL GOOD" AFTER THE REPROGRAMMING. NOTE: FURTHER EVALUATION OF THE EVENT INDICATED THAT THE ABOVE EVENT WAS ALSO REPORTED AS PART OF MANUFACTURER'S REPORT # 3004209178-2010-05015. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114338 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1