BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1892193 · Received November 2, 2010

    Report

    Report Number
    3007566237-2010-08777
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED COMPANY REP INDICATED THAT PT HAD AN ALLERGIC REACTION TO A PREVIOUS PUMP IMPLANT AND HAD THE SYSTEM REMOVED. THE PT RESPONDED WELL TO THE THERAPY AND THEY WERE LOOKING TO FIND A WAY TO RE-IMPLANT THE PT. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL CATHETER, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: