BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3031502 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04511
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GOING TO HAVE A POCKET REVISION THE DAY OF REPORT DUE TO SENSITIVITY AT THE POCKET SITE. THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE 'NEVER HEALED RIGHT.' 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 THE PATIENT WAS GETTING 'GREAT THERAPY'. IMPEDANCES WERE FINE WITH THE IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT NO MALFUNCTIONS WERE 'SEEN OR CAUSED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133667 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