BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5059495 · Received September 6, 2015

    Report

    Report Number
    3004209178-2015-17399
    Event Type
    Malfunction
    Date Received
    September 6, 2015
    Report Date
    August 11, 2015
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37092, LOT# 279290002, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 355031, LOT# N260051,IMPLANTED: (B)(6) 2011, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    THE CONSUMER REPORTED VIA A MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THERE WAS A LOSS OF STIMULATION ON THE RIGHT SIDE FROM THE WAIST TO THE KNEE. THIS OCCURRED APPROXIMATELY A YEAR AGO. THE PATIENT WAS TOLD SHE HAD A BROKEN WIRE PER X-RAY. IMPEDANCES WERE CHECKED ON THE DAY OF THE REPORT, (B)(6) 2015, AND ONE LEAD SHOWED ALL HIGH IMPEDANCES. 0-7 WERE GREATER THAN 10,000. THE REP ATTEMPTED REPROGRAMMING TO INCLUDE CONVENTIONAL STIMULATION AS WELL AS HIGH DENSITY AND HIGH FREQUENCY OPTIONS. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THIS TIME OF REPORT. THE PATIENT WAS GOING TO TRY ALL THE NEW GROUPS TO SEE IF PAIN REDUCTION WOULD OCCUR WITH THESE NEWLY ADDED GROUPS. IF SHE DID NOT GET THE SATISFACTORY RESULTS SHE COULD BE REPROGRAMMED OR DISCUSS FURTHER OPTIONS WITH HER DOCTOR. THE PATIENT WAS GOING TO LET THE REP KNOW. NO SURGICAL INTERVENTION OCCURRED AND IT WAS UNKNOWN IF ANY WAS PLANNED. IT WAS NOTED THAT THE PATIENT WAS IMPLANTED FOR SPINAL STENOSIS AND SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590785 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