BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1250371 · Received December 3, 2008

    Report

    Report Number
    3004209178-2008-07944
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NOTED FLUID AROUND THE PUMP. SOME OF THE FLUID HAD BEEN REMOVED TWO DAYS PRIOR TO THE REPORT; SOME FLUID REMAINED. THE PATIENT CONTINUED TO RECEIVE THERAPY. THE PUMP CONTAINED DILAUDID 2 MG/ML AND BUPIVICAINE 30 MCG/ML. THE HCP LATER REPORTED THAT THE PATIENT HAD A POST-OPERATIVE SEROMA WHICH WAS ASPIRATED AND RESOLVED.

    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 PROGRAMMER: MODEL 8840| CATHETER: MODEL 8731SC| EXPLANTED: