BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1478136 · Received September 16, 2009

    Report

    Report Number
    3004209178-2009-06570
    Event Type
    Injury
    Date Received
    September 16, 2009
    Date of Event
    January 1, 2009
    Report Date
    August 19, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: THE PT ROLLED OVER IN BED A FEW MONTHS AGO AND THE SYSTEM STOPPED WORKING. THE DEVICE WAS REPORTEDLY FULLY CHARGED AT THE TIME OF THE INCIDENT. ATTEMPTS TO INTERROGATE THE IPG WERE TRIED MULTIPLE TIMES WITH NO SUCCESS. IN THE OR THE LEADS WERE TESTED AND FOUND TO BE IN THE CORRECT AREA FOR PARESTHESIA. THE IPG WAS UNABLE TO COMMUNICATE WITH THE PROGRAMMER IN THE OR. A NEW IPF WAS CONNECTED TO THE CURRENT LEADS AND THE PT RECEIVED GOOD STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37743| IMPLANTED:| LEAD: MODEL 3778| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752| LEAD: MODEL 3778