BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2955634 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02526
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2012 TO ACHIEVE MORE COVERAGE SUCCESSFULLY. ON THAT DAY, IT WAS REPORTED THAT THE PATIENT WAS HAVING PROGRESSING PAIN IN AREAS OTHER THAN WHAT THE PATIENT'S SYSTEM WAS IMPLANTED TO TREAT. THE PATIENT WAS THEREFORE REFERRED TO A NEUROLOGIST FOR FURTHER WORKUP OF THE NEW PROBLEM. THE NEUROLOGIST STATED THAT THE PATIENT'S SYSTEM WAS BEING 'REJECTED BY HER BODY' AND NEEDED TO BE EXPLANTED. THE LOCATION OF THE PATIENT'S SYMPTOM WAS NOTED TO BE HER LEGS. IT WAS INDICATED THAT THE PATIENT HAD BEEN REFERRED TO HER IMPLANTING PHYSICIAN FOR FOLLOW-UP. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58179 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