BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1203518 · Received October 17, 2008

    Report

    Report Number
    3004209178-2008-06621
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED A HEMATOMA. THE PATIENT'S CATHETER HAD BEEN PLACED EPIDURAL. IT WAS UNKNOWN IF THE CATHETER WAS INTENTIONALLY PLACED EPIDURAL. THE PATIENT'S PHYSICIAN WAS PLANNING ON REPLACING THE CATHETER USING INTRATHECAL PLACEMENT. NO PATIENT SYMPTOMS WERE REPORTED. THE DRUG USED IN THE PUMP WAS UNKNOWN. 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. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC| PROGRAMMER: MODEL 8840| IMPLANTED: