BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2083018 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03240
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    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 PT HAD THEIR NEUROSTIMULATOR EXPLANTED DUE TO INFECTION AT THE POCKET SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD: MODEL LEAD GES, LOT# UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL LEAD GES, LOT# UNK| EXPLANTED:| IMPLANTED: