BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2133540 · Received June 15, 2011

    Report

    Report Number
    3007566237-2011-04452
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    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

    THE PT'S LEADS WERE REPLACED. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. THE PT WAS DOING WELL FOLLOWING THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 Required Intervention EXPLANTED:| LEAD: MODEL 3889, LOT # UNK| IMPLANTED: