BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2082807 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03203
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    December 1, 2010
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT FEEL THE STIMULATION ON THEIR RIGHT SIDE (WORKING ON LEFT SIDE). THERE WAS NO TRAUMA OR ACCIDENT ASSOCIATED WITH THE EVENT. THE PATIENT MET WITH THE COMPANY REPRESENTATIVE WHO REPROGRAMMED HIM AND COULD NOT FIND ANYTHING WRONG WITH THE DEVICE. SUBSEQUENTLY, THE PATIENT HAD SURGERY TO FIX THE STIMULATION ISSUE. DURING THE PROCEDURE, THE LEAD WAS DISCONNECTED FROM PORT 8-15 OF THE NEUROSTIMULATOR AND IMPEDANCES OF >40000 OHMS WERE SEEN USING THE SNAP-LID DEVICE. THE LEAD ON THE RIGHT WAS THEN REPLACED WHILE THE LEAD ON THE LEFT SIDE WAS LEFT INTACT, BUT HIGH IMPEDANCES WERE SEEN. THE LEADS WERE DISCONNECTED, CLEANED, AND RE-INSERTED SEVERAL TIMES WITH HIGH IMPEDANCES STILL SEEN. THE NEUROSTIMULATOR WAS THEN REPLACED WITH A NEW DEVICE AND HIGH IMPEDANCES AGAIN SEEN. IT WAS NOTED THAT THE PATIENT DID HAVE A "WET" TAP AND A BLOOD PATCH PROCEDURE PERFORMED AT THE SAME SURGERY IN WHICH 20 CC OF BLOOD WAS INJECTED INTO THE EPIDURAL SPACE. WHEN IMPEDANCES WERE CHECKED 30 MINUTES LATER, THE 2 ELECTRODES ON LEAD IN PORT 8-15 HAD GOOD RESULTS, BUT THE OTHER ELECTRODES WERE STILL HIGH. THE LEAD WAS SUBSEQUENTLY CHECKED OUT FINE AND WORKED. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE128273N| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA127591N| LEAD: MODEL 3778, LOT# V247659019| LEAD: MODEL 3778, LOT# V247659021| EXPLANTED:| IMPLANTED: