BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA

    MDR report key: 1071651 · Received July 9, 2008

    Report

    Report Number
    3004209178-2008-03861
    Event Type
    Death
    Date Received
    July 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    June 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED. THE PHYSICIAN DOES NOT SUSPECT THE DEATH WAS RELATED TO THE DEVICE, BUT THE CAUSE OF DEATH COULD NOT BE OBTAINED BY THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXPLANTED:| IMPLANTED:| IMPLANTED:| STIM ACCESSORY MODEL 4351 LOT# NHT005668N| STIM ACCESSORY MODEL 4351 LOT# NHT006271N| EXPLANTED: