BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5988026 · Received September 29, 2016

    Report

    Report Number
    3004209178-2016-20044
    Event Type
    Injury
    Date Received
    September 29, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 29, 2016
    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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3487A-56, LOT# V117138, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V104285, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 377660, LOT# V012086, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER AND A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR CHRONIC LOW BACK PAIN. IT WAS REPORTED THAT THE PATIENT WAS DOING DISHES AT THE TIME, FELT A SNAP AND BURNING PAIN IN THE MIDDLE OF HER BACK AND COULD NOT BEND FORWARD, OR TWIST TO THE LEFT OR RIGHT WITHOUT CAUSING A SEVERE PAIN. THE PATIENT'S WIRE CAME OUT OF HER DEVICE AND WAS COILING AROUND HER MID BACK. THE PATIENT WOKE UP AND HER BACK WAS HURTING. SHE LOOKED IN A MIRROR AND NOTICED THAT WHERE HER SCAR FOR THE LEAD IMPLANT IS, INSTEAD OF THE LEADS GOING STRAIGHT UP, THERE WAS ONE LEAD COILED INTO A CIRCLE AND PROTRUDING HER SKIN. IT WAS EXTREMELY PAINFUL. THE PATIENT HAD AN APPOINTMENT WITH HER HEALTH CARE PROVIDER REGARDING THIS ISSUE ON (B)(6) 2016 TO GET A PRINT OUT OF HER DEVICE AND THEN SHE WOULD GO INTO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639140 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 28 YR Required Intervention