BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3851190 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10166
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 30, 2014
    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

    CONCOMITANT PRODUCT: PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37092, LOT # 265250001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S DEVICE CONTROLLED THEIR LEG AND LOW BACK PAIN FOR A WEEK AFTER IMPLANT. IT WAS NOTED THE PATIENT¿S PAIN CONTROL QUICKLY LESSENED AFTER THAT. IT WAS REPORTED THE PATIENT HAD CRAMPING IN THE POSTERIOR THORACIC AREA AND DIAPHRAGM THAT MADE BREATHING DIFFICULT AND PAINFUL. IT WAS NOTED THAT ONE OF THE PATIENT¿S PROGRAMS GAVE THEM A TINGLING SENSATION IN A SMALL SEGMENT OF THEIR LEGS, WHICH WAS NOT THE DESIRED LOCATION. IT WAS REPORTED THE PROGRAM ALSO CAUSED BILATERAL LEG WEAKNESS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SPINAL CORD STIMULATION (SCS) WAS NO LONGER FUNCTIONING FOR THE PATIENT SO SHE STOPPED USING IT. IT WAS NOTED THAT THE PATIENT HAD SOME UNPLEASANT STIMULATION AND THE COVERAGE TO THE LOWER BACK WAS INSUFFICIENT. IT WAS NOTED THAT THE PATIENT HAD TO STRUGGLE WITH THE CHARGING OF THE DEVICE SO SHE STOPPED USING IT. THE REPORTER NOTED THAT IT WAS MORE DUE TO PATIENT COMPLIANCE THAN THE DEVICE ISSUE. IT WAS NOTED THAT THE PATIENT WAS SEEN IN (B)(6) 2011, THEN ON (B)(6) 2014 AND FINALLY ON (B)(6) 2014 FOR THE EXPLANT OF THE SCS DEVICES. IT WAS FURTHER NOTED THAT BECAUSE THE PATIENT DID NOT CHARGE THE UNIT, THE UNIT ACTUALLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329927 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 00052 YR Required Intervention