BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 1934206 · Received December 8, 2010

    Report

    Report Number
    3004209178-2010-10327
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    May 1, 2009
    Report Date
    November 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PROBLEMS WITH DEVICE SINCE IT WAS IMPLANTED. THE STIMULATION WAS WORKING ON ONE SIDE, HOWEVER, NOT THE OTHER. THE MANUFACTURER'S REPRESENTATIVE HAD TRIED EVERYTHING TO GET IT TO WORK WITHOUT SUCCESS. IT WAS UNCLEAR WHAT WAS WRONG WITH THE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 65 YR LEAD: MODEL 39565-30, LOT #: N167667001| EXTENSION: MODEL 37081, LOT #: NJB026207V| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #: NKE122804N| ACCESSORY: MODEL 37752, LOT #: NKA118663N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT #: NJB045979V| IMPLANTED: