BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1830806 · Received September 8, 2010

    Report

    Report Number
    3007566237-2010-06854
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    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 REPLACED BECAUSE, IT WAS NOT RECOGNIZED BY THE CLINICIAN PROGRAMMER. IT WAS BELIEVED THAT THIS EVENT MAY BE RELATED TO THE PT'S HIGH SETTINGS. SINCE THE REPLACEMENT SURGERY, THE PT WAS REPORTED AS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC NEUROMODULATION 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention LEAD: MODEL 4351, LOT# UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# UNK| IMPLANTED:| EXPLANTED: