BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3172719 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10439
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 28, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3888-45, LOT# V745830, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE CAUSE OF THE EVENT WAS ADAPTIVE STIMULATION. THERE WERE NO ABNORMAL IMPEDANCES. IT WAS UNKNOWN IF THERE WAS ANY REPROGRAMMING. IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WOULD "TURN ITSELF DOWN AND THEN TURN ITSELF UP SO HIGH THAT IT WOULD MAKE THE PATIENTS' KNEES BUCKLE". IT WAS STATED THAT (B)(6) 2013 WAS THE FIRST DAY THAT THE INS "BEGAN TO TURN ITSELF DOWN" AND ON (B)(6) 2013 IS WHEN THE INS "FIRST BEGAN TO TURN ITSELF UP". IT WAS NOTED THAT THE PATIENT HAD BEEN IN SITTING AND STANDING POSITIONS WHEN THIS HAPPENED. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN AT VARIOUS LOCATIONS SUCH AS: THE PATIENT'S HOME, (B)(4), A CAR, AND CHURCH. IT WAS STATED THAT THE PATIENT HAD NOT TURNED THEIR INS OFF TO DETERMINE IF THIS HAPPENS WHEN THE DEVICE WAS OFF AS WELL. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. IT WAS REPORTED THAT THE PATIENT HAD NOT ADJUSTED HER STIMULATION BECAUSE "BY THE TIME SHE GOT HER PROGRAMMER, STIMULATION WAS BACK AT A COMFORTABLE SETTING". IT WAS NOTED THAT TURNING THE DEVICE OFF WAS UNCOMFORTABLE FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273679 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR