BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA

    MDR report key: 1002289 · Received February 22, 2008

    Report

    Report Number
    6000030-2008-00897
    Event Type
    Injury
    Date Received
    February 22, 2008
    Report Date
    February 13, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED SEIZURES AND WAS ADMITTED TO THE INTENSIVE CARE UNIT OF THE HOSPITAL. THE PUMP CONTAINED BACLOFEN; THE CALLER DID NOT HAVE ACCESS TO A PROGRAMMER AT THE TIME OF THE CALL, BUT PLANNED TO CONTACT THE MANAGING HCP. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK MEDTRONIC VASCULAR 8711 J0058209R

    Patients

    Seq Age Sex Outcome Treatment
    1 YR PUMP MODEL# 863740| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED| EXPLANTED