BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1872196 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07940
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    December 15, 2008
    Report Date
    December 15, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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. 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 CAN NOT USE THEIR PT PROGRAMMER. THE PT CAN TURN STIMULATION ON AND OFF. THE ISSUE IS CORRECTABLE BY INTERROGATION. THIS IS A RARE AND CORRECTABLE ISSUE. 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

    A MFR'S REP REPORTED THAT THE PT WAS NOT ABLE TO ADJUST HER STIMULATION. THE PT PROGRAMMER WAS INTERROGATED AND IT BEGAN "FUNCTIONING PROPERLY." NO PT SYMPTOMS WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL 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 47 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB037513V| PROGRAMMER: MODEL 37743, LOT# NKE112189N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB039628V| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA116190N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V104161033| LEAD: MODEL 3777, LOT# V107419013| EXPLANTED: