BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1943896 · Received December 28, 2010

    Report

    Report Number
    3004209178-2010-10816
    Event Type
    Injury
    Date Received
    December 28, 2010
    Report Date
    December 22, 2010
    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 PTS LEAD HAD ERODED INTO HER STOMACH. THE PT WAS SEEING A NEW PHYSICIAN AND PLANNED TO HAVE THE DEVICE REMOVED. THE PHYSICIAN DID NOT PLAN TO RETURN THE DEVICE. ADDITIONAL INFO WAS REQUESTED.

    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 4351, LOT #: NHT007008N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT #: NHT006892N