BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1981393 · Received February 1, 2011

    Report

    Report Number
    3004209178-2011-00768
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    MDT 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).

    Description of Event or Problem · 1

    THE IMPLANTABLE NEUROSTIMULATOR BECAME INFECTED. IT WAS REMOVED. THE PROXIMAL EXTENSIONS WERE CUT AND REMOVED WITH THE NEUROSTIMULATOR (REFERENCE MFG. REPORT # 3004209178201100729). THE INFECTION RESOLVED. THE SURGEON PLANNED ON EXPOSING THE PROXIMAL ENDS OF THE LEADS, TESTING THE LEADS AND ATTACHING THEM TO A NEW EXTENSION IF THEY WERE FUNCTIONING PROPERLY. THIS WAS DONE. IMPEDANCES WERE TESTED FROM THE NEW EXTENSION AND IMPLANTABLE NEUROSTIMULATOR. IMPEDANCES WERE HIGH OUT-OF-RANGE ON ALL 8 ELECTRODES. THE PATIENT FELT NO PARESTHESIA. THE EXTENSION WAS REMOVED FROM THE IMPLANTABLE NEUROSTIMULATOR AND CLEANED: THE NEUROSTIMULATOR WAS ASPIRATED. THE HIGH IMPEDANCES/NO STIMULATION PERSISTED. THE EXTENSION WAS CONNECTED TO AN EXTERNAL STIMULATOR VIA A SNAP LID CONNECTOR. IMPEDANCE TESTING AND TEST STIMULATION WAS SUCCESSFUL. THE EXTENSION WAS AGAIN CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR AND INSERTED INTO THE 8-15 SOCKET INSTEAD OF THE 0-7 SOCKET. AGAIN IMPEDANCES WERE OUT OF RANGE AND NO TEST STIMULATION WAS ACHIEVED. THE DEVICE HAD COMMUNICATED NORMALLY WITH THE PHYSICIAN PROGRAMMER THROUGHOUT THESE EVENTS. A NEW IMPLANTABLE NEUROSTIMULATOR WAS OPENED AND CONNECTED. TEST STIMULATION WAS SUCCESSFUL. ADDITIONALLY, 1 OF THE 2 EXISTING LEADS MOVED OUT OF POSITION WHILE CONNECTING THE NEW EXTENSION TO THEM. PARESTHESIA WAS UNCOMFORTABLE ON THE LEAD THAT HAD MOVED. THIS LEAD WAS NOT ABLE TO BE USED TO PROVIDE THERAPY. THERAPEUTIC, USEFUL STIMULATION WAS PROGRAMMED IN RECOVERY. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THESE EVENTS. THE HCP PLANNED ON ADDING ANOTHER LEAD IN THE FUTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE158970N| STIM ACCESSORY: MODEL 37092, LOT# 263630002| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB008771V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0114132V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0114132V| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA150406N| IMPLANTED: