BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2172601 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-05602
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SWELLING IN HER FEET SINCE IMPLANT. BEGINNING ON (B)(6) 2011 BOTH OF THE PT'S FEET WERE SWOLLEN, AND THEN ONLY THE LEFT FOOT WAS AFFECTED. HOWEVER, THE PT'S RIGHT FOOT HAD REDNESS AS A RESULT OF SKIN STRETCHING. THE PT WAS ADMITTED TO THE HOSPITAL. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 51 YR Hospitalization| R IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V711815| LEAD: MODEL 3888, LOT# V483090| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE168276N| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB007835V| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB010257V| EXPLANTED:| LEAD: MODEL 3888, LOT# V641568| EXPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA153766N| IMPLANTED:| LEAD: MODEL 3888, LOT# V597862| EXPLANTED:| EXPLANTED: