BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2862687 · Received December 10, 2012

    Report

    Report Number
    3007566237-2012-02940
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 12, 2012
    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
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN IN A CAR ACCIDENT TWO YEARS AGO AND THE WHOLE SYSTEM HAD HAD TO BE REPLACED BECAUSE IT HAD BEEN "KNOCKED OFF HER SPINE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT: 'WHEN SHE FELL IN 2011, THE LEAD MIGRATION WAS LINKED FROM A CAR ACCIDENT, THAT'S WHY WE REPLACED.' FOR INFORMATION ABOUT THE FALL IN 2011 PLEASE REFER TO MANUFACTURE REPORT # 3004209178-2012-11226.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention