BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2610017 · Received June 11, 2012

    Report

    Report Number
    3004209178-2012-04285
    Event Type
    Injury
    Date Received
    June 11, 2012
    Report Date
    May 9, 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
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    RECHARGER MODEL 37752 SERIAL# (B)(4) PROGRAMMER MODEL 37743 SERIAL# (B)(4) EXTENSION MODEL 37082-20 SERIAL# (B)(4) IMPLANTED: 2009-(B)(6) EXPLANTED: NA LEAD MODEL 3093-33 LOT# V182832 IMPLANTED: 2009-(B)(6) EXPLANTED: NA LEAD MODEL 3093-33 LOT# V179759 IMPLANTED: 2009-(B)(6) EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED NUMBNESS ON THEIR ENTIRE RIGHT SIDE. IT WAS ALSO NOTED THAT THE PATIENT WAS ONLY ABLE TO CHARGE FOR A MINUTE THEN WOULD GET AN ERROR CODE MESSAGE TO CALL THEIR DOCTOR. THE PATIENT ALSO STATED THEY NEED AN MRI. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION FOR THE LAST 5-6 MONTHS. IT WAS STATED THAT BACK IN (B)(6), THE PATIENT WOULD HAVE STIMULATION TURNED UP TO 4.5V, BUT BARELY FELT THE STIMULATION. IT WAS FURTHER STATED THAT THE RIGHT SIDE OF THEIR BODY FELT "KNOT" THAT CAUSED IRRITATION WAS REPORTED, BUT WAS NO LONGER PRESENT AS OF THE DATE OF THIS REPORT. NO ACCIDENT OR INCIDENT WAS REPORTED IN RELATION TO THIS EVENT. THE PATIENT EXPERIENCED THEIR SYMPTOMS AT THE LEAD AND IMPLANTABLE NEUROSTIMULATOR LOCATIONS. IT WAS INDICATED THAT THE DEVICE WAS NOT WORKING AND COULD NOT BE CHARGED. IT WAS ADDED THAT THE PATIENT WAS NO LONGER IN THE PAIN THEY WERE WHEN IMPLANTED IN 2009. IT WAS NOTED THAT THE PATIENT WANTED THE WHOLE SYSTEM REMOVED. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THE PATIENT WAS STILL EXPERIENCING PROBLEMS WITH THE DEVICE. IT WAS NOTED THE DEVICE HAD "GONE OUT." THE PATIENT WAS SEEKING A PHYSICIAN IN HER AREA AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 00041 YR Required Intervention