BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1993777 · Received January 13, 2011

    Report

    Report Number
    3004209178-2011-00353
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 4, 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

    IT WAS STATED THE PT WAS GETTING GOOD STIMULATION AND THEN IT QUIT WORKING. AN ERROR CODE OF 574 WAS DISPLAYED. THE PT WAS SET TO MEET WITH A MANUFACTURER REPRESENTATIVE TO REINSTATE THE DEVICE PROGRAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE160029N| EXPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# N272326| IMPLANTED:| LEAD: MODEL 3778, LOT# V558088001| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA148651N| LEAD: MODEL 3778, LOT# V442844012