BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPG GENERAL

    MDR report key: 1940801 · Received December 23, 2010

    Report

    Report Number
    3007566237-2010-10747
    Event Type
    Injury
    Date Received
    December 23, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ENTERRA PT HAD A REPLACEMENT DUE TO INFECTION. FURTHER INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPG GENERAL LGW MEDTRONIC NEUROMODULATION IPG GES NA

    Patients

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