BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCRHOMED II

    MDR report key: 1180184 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06116
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 3, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO INFECTION. SPECIFIC SYMPTOMS OR OUTCOME WERE NOT REPORTED. THE PUMP CONTAINED LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCRHOMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention EXPLANTED| CATHETER MODEL 8711| PROGRAMMER MODEL 8840| ACCESSORY MODEL 8590-1| EXPLANTED