BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2073613 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-03136
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    June 21, 2010
    Report Date
    April 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    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 REPORTED THAT THE DEVICE SYSTEM WAS EXPLANTED DUE TO INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.

    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 59 YR Required Intervention IMPLANTED:| LEAD: MODEL 3777, LOT # V323694021| IMPLANTED:| LEAD: MODEL 3777, LOT # V247699030| PROGRAMMER: MODEL 37743, LOT # NKE148324N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA139369N| EXPLANTED:| EXPLANTED: