BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1051107 · Received May 22, 2008

    Report

    Report Number
    3004209178-2008-02738
    Event Type
    Injury
    Date Received
    May 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. NO SPECIFIC SYMPTOMS WERE REPORTED. THE PUMP AND CATHETER WERE EXPLANTED (DATE UNKNOWN). THE PUMP WAS USED TO DELIVER MORPHINE, CONCENTRATION AND DOSAGE UNKNOWN. THE HCP INDICATED THAT THE PATIENT RECOVERED WITH SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL 8709SC LOT# N116493002| EXPLANTED: