BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1902271 · Received November 15, 2010

    Report

    Report Number
    3007566237-2010-09475
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT DEVICE IMPLANT ON (B)(6) 2010. THE DOCTOR PERFORMED A LAMINECTOMY AT T10, USING THE SMALL PASSING ELEVATOR FIRST WITH ONE PASS, THEN PLACED THE LEAD WITHOUT INCIDENT/NO RESISTANCE. IMAGE WAS TAKEN USING C-ARM, THE LEAD APPEARED TO BE MORE TOWARD THE PATIENT'S LEFT, AND AT THE LEVEL OF MID T7. THE LEAD WAS REMOVED AND PASSED ONE MORE TIME WITHOUT INCIDENT/NO RESISTANCE, IMAGE WAS TAKEN AFTER PLACEMENT WITH C-ARM. LEAD APPEARED MORE MIDLINE, AGAIN AT LEVEL OF MID T7. THE LEAD WAS ANCHORED, TUNNELED TO POCKET, SET LEAD IN THE NEUROSTIMULATOR (INS), IMPEDANCES WERE CHECKED, NOTHING WAS OUT OF RANGE, AND INCISIONS WERE CLOSED. WHEN THE PATIENT WOKE UP AT 0925 IN PACU, HE COMPLAINED OF BILATERAL LOW RIB PAIN AND MOVED RIGHT LEG SPONTANEOUSLY. THE NURSE DID HER NEURO ASSESSMENT AND PATIENT WAS NOT ABLE TO MOVE HIS LEFT LEG AND HAD NO SENSATION IN THE LEFT LEG. THE DOCTOR WAS INFORMED AND HE TALKED TO PATIENT ABOUT GOING BACK TO SURGERY TO HAVE THE ENTIRE SYSTEM REMOVED. BY 1020, HE NO LONGER HAD SENSATION OR MOVEMENT IN RIGHT LEG EITHER. BY 1125, THE PATIENT HAD BEEN BROUGHT BACK TO THE OPERATING ROOM AND THE LEAD AND INS WERE REMOVED. THE POCKET WAS OPENED AND STIMULATOR WAS ALSO REMOVED. PATIENT WAS BACK TO PACU FOR A SECOND TIME BY 1200. AT THIS TIME HE WAS ABLE TO MOVE RIGHT LEG SPONTANEOUSLY, HAD SENSATION IN HIS RIGHT AND LEFT LEG BUT NO MOVEMENT IN HIS LEFT LEG AND NO COMPLAINT OF RIB PAIN. BY 1230, HE CONTINUED TO HAVE SENSATION IN RIGHT AND LEFT LEG, SPONTANEOUS MOVEMENT IN HIS RIGHT LEG, AND HAD WEAK MOVEMENT IN HIS LEFT LEG FROM HIP TO COMMAND. HE WAS ADMITTED TO THE ORTHO/NEURO FLOOR. ON (B)(6) 2010, HE CONTINUED TO HAVE SENSATION IN RIGHT AND LEFT LEG, MOVEMENT IN RIGHT LEG BUT MOVEMENT IN LEFT LEG REMAINED WEAK. THE LEAD AND INS WILL BE RETURNED. FURTHER INFORMATION HAS BEEN REQUESTED.

    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 Required Intervention| S EXPLANTED:| LEAD: MODEL 39565, LOT# UNK| IMPLANTED: