BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1920112 · Received December 3, 2010

    Report

    Report Number
    3004209178-2010-10175
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    May 18, 2010
    Report Date
    November 22, 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).

    Description of Event or Problem · 1

    THE DEVICE UNDERWENT NUMEROUS OVERDISCHARGES AND IT WAS NO LONGER FUNCTIONING. IT WAS REPLACED AND WAS NOT TO BE RETURNED FOR ANALYSIS. THE PATIENT WAS STATED TO BE "DOING FINE".

    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 59 YR Required Intervention EXPLANTED:| ACCESSORY: MODEL #37752, LOT #NKA033914N| LEAD: MODEL #3778, LOT #V058293018| IMPLANTED:| IMPLANTED:| LEAD: MODEL #3778, LOT #V059898037| EXPLANTED:| PROGRAMMER: MODEL #37742, LOT #NJD056574N