BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1001558 · Received February 21, 2008

    Report

    Report Number
    3004209178-2008-00835
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 1, 2008
    Report Date
    January 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SORE ON THE INCISION OF THE PUMP. THE PATIENT SAW THE MANAGING PHYSICIAN AND WAS REFERRED TO THE SURGEON. THE SURGEON ORIGINALLY THOUGHT THAT THE PUMP WAS ERODING DUE TO THE PATIENT'S THINNESS AND WAS PLANNING TO PLACE THE PUMP DEEPER IN THE POCKET. WHEN THE PUMP POCKET WAS OPENED THE HCP FOUND WHITISH DRAINAGE IN THE POCKET WHICH THE HCP CULTURED. THE RESULTS OF THE CULTURE ARE UNK. THE PUMP AND CATHETER WERE REMOVED. NO PATIENT OUTCOME WAS REPORTED. THE PATIENT'S PUMP CONTAINED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    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 35 YR Required Intervention EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK IMPLANTED| EXPLANTED| CATHETER MODEL 8709 LOT# N100824019 IMPLANTED