BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1161188 · Received September 15, 2008

    Report

    Report Number
    3004209178-2008-05767
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 19, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THE PUMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH WAS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT'S INTRATHECAL DRUG DELIVERY DEVICE WAS EXPLANTED DUE TO INFECTION. NO PATIENT SYMPTOMS, TREATMENTS OR OUTCOME WERE REPORTED. THE DRUG USED IN THE PUMP WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| CATHETER MODEL 8709SC LOT# N148522014| EXPLANTED:| CATHETER MODEL 8596SC LOT# N108931025| EXPLANTED:| IMPLANTED: