BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1061416 · Received June 17, 2008

    Report

    Report Number
    2182207-2008-03271
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 20, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CATHETER COMPLICATION AND UNDERWENT A CATHETER REVISION IN 2008. THE HCP REPORTED THAT THE CATHETER APPEARED TO HAVE BEEN CUT DURING INITIAL IMPLANTATION. IT IS UNKNOWN WHAT DRUG WAS IN THE PUMP. NO PATIENT SYMPTOMS OR FINAL OUTCOME WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention IMPLANTED:| PROGRAMMER MODEL 8840| CATHETER MODEL#: 8709SC LOT# N111022005| EXPLANTED: