BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3851724 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10201
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 16, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH CANCER AND LOST HER BALANCE AND FELL A FEW DAYS PRIOR TO THE DATE OF THE REPORT. THE PATIENT ASKED IF THIS WOULD HAVE ANYTHING TO DO WITH MOVING THE ELECTRODES, BECAUSE THEY WEREGETTING STRONG SHOCKS AT THE TIME OF THE REPORT WERE NOT ABLE TO TURN DOWN STIMULATION. IT WAS NOTED THAT ¿PRETTY MUCH THE NEXT DAY¿ AFTER THE FALL THEY STARTED GETTING SHOCKING. THE PATIENT REPORTEDLY TRIED TO TURN STIMULATION OFF BUT IT SEEMED LIKE IT WOULD NOT TURN OFF COMPLETELY. THE PATIENT WAS ASSISTED IN USING THE PATIENT PROGRAMMER AND THE PATIENT REPORTED THAT STIMULATION WAS AT 0.0 BUT WAS STILL TURNED ON. THE PATIENT WAS INSTRUCTED ON HOW TO TURN STIMULATION OFF AND THE PATIENT CONFIRMED THAT THEY WERE SUCCESSFUL IN TURNING STIMULATION OFF. IT WAS SUGGESTED THAT THE PATIENT KEEP STIMULATION OFF UNTIL THEY COULD FOLLOW UP WITH THEIR HEALTH CARE PROVIDER (HCP). THE PATIENT WAS REPORTEDLY GOING TO HAVE AN MRI BECAUSE OF THEIR CANCER DIAGNOSIS. THE PATIENT WAS ALSO SCHEDULED TO HAVE A PET SCAN THE WEEK FOLLOWING THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329412 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 00068 YR