BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1150239 · Received September 3, 2008

    Report

    Report Number
    2182207-2008-05412
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    June 1, 2008
    Report Date
    August 10, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED POOR PAIN COVERAGE. AN X-RAY REVEALED THE CATHETER WAS 1 CM FROM BEING EXPOSED FROM THE INTRATHECAL SPACE. THE SYSTEM WAS EXPLANTED AND REPLACED. THE PT RECOVERED WITHOUT SEQUELA. THE PT'S PUMP WAS USED TO DELIVER HYDROMORPHONE 10 MG/ML AT 1.32 MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| CATHETER MODEL 8709 LOT# J11788R18 IMPLANTED: