BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1001559 · Received February 21, 2008

    Report

    Report Number
    3004209178-2008-00843
    Event Type
    Injury
    Date Received
    February 21, 2008
    Report Date
    January 11, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. THE REPORT WAS SUBMITTED LATE BY THE MANUFACTURER'S REPRESENTATIVE, RETRAINING HAS BEEN CONDUCTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICES WERE REMOVED DUE TO AN INFECTION. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 69 YR Required Intervention EXPLANTED| CATHETER MODEL 8731SC LOT# N124970020 IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK IMPLANTED