BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1231232 · Received November 13, 2008

    Report

    Report Number
    2182207-2008-07423
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD GOOD STIMULATION IN THE OPERATING ROOM DURING IMPLANT SURGERY. THE LEAD WAS PLACED DIRECTLY INTO THE STIMULATOR CONNECTOR BLOCK. POST-OPERATIVELY, THE PT EXPERIENCED NO STIMULATION. IMPEDANCES ON CONTACTS 0 THROUGH 7 WERE >40,000 OHMS. CONTACTS 8 THROUGH 15 WERE PLUGGED. THE DOCTOR PLANNED TO HAVE THE PT RETURN TO SURGERY TO INVESTIGATE. THE DOCTOR PLANNED TO HAVE THE PT AWAKE DURING THE PROCEDURE AND TO TEST THE LEAD DIRECTLY. THE OUTCOME IS UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC NEUROMODULATION 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LEAD: MODEL UNK| EXPLANTED: