BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1061193 · Received June 16, 2008

    Report

    Report Number
    3004209178-2008-03257
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD PART OF HIS COLON REMOVED AND HAD FORMED AN ILEUS. THE PHYSICIAN INDICATED THAT THE ILEUS FORMED DUE TO IMMOBILITY AND THE BACLOFEN PUMP. THE PT HAS BEEN IN THE HOSPITAL FOR 3 WEEKS. THE PUMP WAS USED TO DELIVER BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, 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 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PROGRAMMER 8840 LOT#: UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT# N064786034