BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2032461 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02291
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 15, 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
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THEIR NEUROSTIMULATOR AND LEADS EXPLANTED TO HAVE AN MRI PROCEDURE. IT WAS THOUGHT THAT THE PT HAD MULTIPLE SCLEROSIS, BUT THE MRI RULED THAT OUT. IT WAS ALSO REPORTED THAT ONE OF THE LEADS HAD "MALFUNCTIONED" AND A REVISION WAS PERFORMED. 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 29 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT007379N| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT007541N| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT007039N