BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1812594 · Received August 17, 2010

    Report

    Report Number
    3007566237-2010-06180
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 19, 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 SYSTEM WAS EXPLANTED DUE TO SHOCKING. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC NEUROMODULATION 4351 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE PULSE GENERATOR: MODEL 3116, LOT #UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL 3116, LOT# UNK| IMPLANTED: