BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3943563 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13217
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 25, 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
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE HEALTH CARE PROVIDER (HCP) HAD NOT SEEN OR HEARD FROM THE PATIENT SINCE THE IMPLANTATION OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE ER WITH ¿EXCRUCIATING PAIN.¿ IT WAS SUSPECTED THAT THE DEVICE WAS ¿MISFIRING¿ BUT THE ER NURSE WAS NOT SURE. STIMULATION WAS IN THE WRONG LOCATION. THE PATIENT WAS HAVING STIMULATION THAT WAS COMING FROM HER BACK AND WRAPPING AROUND TO HER ABDOMEN. TYPICALLY THE PATIENT WOULD FEEL STIMULATION IN HER FOOT WHICH WAS WHAT THE DEVICE WAS IMPLANTED FOR. THE PATIENT NO LONGER FELT STIMULATION IN THE FOOT AND HER FOOT WAS HURTING. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE COMPLAINT. THE PATIENT RECENTLY MOVED AND DID NOT HAVE AN ESTABLISHED HEALTH CARE PROVIDER (HCP) IN THE AREA. THE PATIENT DID NOT HAVE HER PATIENT PROGRAMMER (PP) WITH TO ADJUST OR TURN OFF THE DEVICE. THE PATIENT HAD BEEN IN BED FOR THE PAST FIVE DAYS WHICH WAS AROUND THE TIME THE ISSUE STARTED. A COUPLE WEEKS LATER IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. TEN DAYS LATER, IT WAS CONFIRMED THAT A COMPANY REPRESENTATIVE CAME AND SAW THE PATIENT IN THE ER. THE COMPANY REPRESENTATIVE STATED IT WAS A QUICK IN AND OUT VISIT. THE DEVICE WAS PROGRAMMED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422315 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 00044 YR Hospitalization