BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3080200 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06954
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 12, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT THE IMPLANT SITE AND IN THE LEG. IT WAS NOTED THAT THE PATIENT COULD NOT TURN ON THE DEVICE BECAUSE THE PAIN INCREASED. IT WAS NOTED THAT A MANUFACTURING REPRESENTATIVE TRIED TO REPROGRAM THE DEVICE BUT COULD NOT BECAUSE IT WAS TOO PAINFUL WHEN DEVICE WAS TURNED ON. IT WAS NOTED THAT MANUFACTURING REPRESENTATIVE CHECKED THE DEVICE AND DETERMINED IT WAS 'OK.' IT WAS NOTED THAT THE PATIENT'S PHYSICIAN 'WANTED TO CHARGE THEM AGAIN TO TAKE IT OUT.' IT WAS FURTHER NOTED THAT PATIENT BENT OVER 'ABOUT 2 MONTHS AGO' PRIOR TO THE REPORT, IN (B)(6) 2013, AND EXPERIENCED A 'SHARP PAIN IN THE GENERATOR AREA.' IT WAS NOTED THAT THE PATIENT WAS ADMITTED BECAUSE OF HER PAIN. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WAS UNABLE TO 'PIN POINT' THE CAUSE OF PAIN AT THE TIME. IT WAS NOTED THAT PATIENT PARALYSIS WAS IN THE RIGHT LEG. IT WAS NOTED THAT THE PATIENT WAS 'SORE AROUND THE GENERATOR AND HAD A LOT OF PAIN IN HER LEFT LEG ALL THE WAY DOWN TO HER TOE.' IT WAS FURTHER NOTED THAT THE MANUFACTURING REPRESENTATIVE DID A DIAGNOSTIC TEST TO CHECK THE LEADS BUT WAS NOT ABLE TO LEAVE IT ON LONG BECAUSE IT HURT THE PATIENT. IT WAS NOTED THAT THE DEVICE HAD NOT BEEN TURNED ON SINCE THE TEST. IT WAS NOTED THAT THE HCP WAS UNABLE TO DO AN MRI BECAUSE OF THE IMPLANTABLE NEUROSTIMULATOR (INS). HCP SUGGESTED REMOVAL OF THE DEVICE BECAUSE 'IT WAS NOT FUNCTIONING.' IT WAS NOTED PATIENT 'CAN HARDLY RIDE IN A CAR' BECAUSE OF THE PAIN. IT WAS FURTHER NOTED THAT THE REPORTED WAS SAYING PATIENT'S TRIP TO THE EMERGENCY ROOM WAS 'ABOUT THREE WEEKS AGO' WHICH IS DIFFERENT THAN PREVIOUSLY REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180807 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 Hospitalization