BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 1051110 · Received May 22, 2008

    Report

    Report Number
    3004209178-2008-02742
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    February 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SKIN OVER THE PATIENT'S ENTERRA IPG ERODED AND THE DEVICE WAS EXPLANTED. THE HCP CONFIRMED THAT THERE WAS EROSION, WOULD DEHISCENCE, AND INFECTION AT THE IPG SITE AND THE DEVICE WAS EXPLANTED. A NEW DEVICE WAS IMPLANTED THREE WEEKS LATER WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| LEAD MODEL 4351| LEAD MODEL 4351| IMPLANTED:| EXPLANTED: