BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2792625 · Received October 16, 2012

    Report

    Report Number
    3004209178-2012-09220
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 28, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS IN THE HOSPITAL ON MONDAY AND TUESDAY BECAUSE, THE DEVICE "WASN'T WORKING PROPERLY". THE PATIENT WAS NOT SURE WHICH DATE WAS CORRECT THE (B)(6). THE STIMULATION "INTENSIFIES TOO MUCH" AND WAS PAINFUL WHEN THE PATIENT "LAYS DOWN, SITS DOWN, OR TOUCHES HER BACK TO SOMETHING". THE DEVICE HAS BEEN TURNED OFF. THE MANUFACTURES REPRESENTATIVE MET WITH HER AT THE HOSPITAL TO "TEST IT" AND COULD NOT RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization