BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2172598 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-05607
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    September 14, 2009
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE EMERGING FROM ANESTHESIA AFTER IMPLANT, THE PT VOMITED. ON HER WAY HOME, THE PT DEVELOPED A FEVER OF 103 DEGREES FAHRENHEIT AND EXPERIENCED SHORTNESS OF BREATH. SHE RETURNED TO THE HOSPITAL AND PRESENTED TO THE EMERGENCY ROOM WHERE SHE WAS ADMITTED TO RULE OUT ASPIRATION PNEUMONITIS.

    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 72 YR Hospitalization| R IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3887, LOT# J0454930V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU126754V| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427,| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3887, LOT# V004177| EXPLANTED:| IMPLANTED:| ADAPTER: MODEL 74002, LOT# N212501| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU126755V| EXPLANTED:| LOT# NFE153522H| ACCESSORY: MODEL 37651, LOT# NKA135580N| PROGRAMMER: MODEL 37743, LOT# NKE133511N| PROGRAMMER: MODEL 7435, LOT# NFT059573P