BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1970999 · Received January 6, 2011

    Report

    Report Number
    3004209178-2011-00107
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    August 1, 2010
    Report Date
    September 28, 2010
    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). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE. (B)(4): ANALYSIS OF SIMILAR DEVICES INDICATED THAT THE ROOT CAUSE OF THIS EVENT IS A MEMORY ERROR IN THE IMPLANTABLE NEUROSTIMULATOR. THE PT CONTINUES TO RECEIVE THERAPY, HOWEVER, THEY CANNOT USE THEIR PT PROGRAMMER. THE PT CAN TURN STIMULATION ON AND OFF WITH THE RECHARGER. THE NEUROSTIMULATOR CAN BE PROGRAMMED WITH THE PHYSICIAN PROGRAMMER. THERE IS NO LOSS OF THERAPY WHEN THIS ISSUE OCCURS. THERE IS NO RISK TO THE PT, BUT THE PT DOES NEED TO VISIT THEIR HCP TO INTERROGATE THE DEVICE AND RESOLVE THE PROBLEM.

    Description of Event or Problem · 1

    THE PT EXPERIENCED OVERSTIMULATION SENSATION AND STIMULATION IN HER STOMACH. THE PT RECHARGED THE IMPLANTABLE NEUROSTIMULATOR. THE PT WAS ABLE TO USE THE PT PROGRAMMER ONCE AFTER RECHARGING. AFTERWARD, WHEN SHE TRIED TO ADJUST STIMULATION, THE PT PROGRAMMER DISPLAYED THE "OUT OF BOX" ICON. STIMULATION WAS STILL ON. THE PT WAS SEEN BY A FIELD REP. THE IMPLANTABLE NEUROSTIMULATOR WAS ABLE TO BE INTERROGATED WITH THE PHYSICIAN PROGRAMMER. PROGRAMMING APPEARED TO BE INTACT. DEVICE INTERROGATION REVEALED NORMAL IMPEDANCES. STIMULATION FELT WEAKER, SO THE FIELD REP INCREASED STIMULATION PARAMETERS. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 18 YR IMPLANTED:| LEAD: MODEL 3487A, LOT# V188124| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE123020N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V211504022| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V196547| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB001607V