BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1190362 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-06341
    Event Type
    Injury
    Date Received
    October 6, 2008
    Report Date
    September 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO ANOMALY FOUND - NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO INFECTION. NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT. SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE HCP FOR ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNKNOWN| CATHETER MODEL 8711 LOT # N106849003 IMPLANTED| EXPLANTED