BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERRA

    MDR report key: 2043138 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02303
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING AN UNSPECIFIED, UNRELATED SURGICAL PROCEDURE. SINCE THAT TIME, THE PT HAD NOT BEEN "FEELING GOOD" AND WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2011. 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 MDT PUERTO RICO OPERATIONS CO., JUNCOS 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR LEAD: MODEL 4351, LOT# NHT008907N| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT008908N| EXPLANTED:| IMPLANTED:| EXPLANTED: