BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2094003 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03502
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS OF THE PUMP CONNECTOR 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

    THE PUMP CONTAINED DILAUDID AND CLONIDINE. THE PT EXPERIENCED A SEROMA. THE PT BELIEVED THE PUMP WAS FLIPPING. THE PT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2011 WHEN 420 MLS OF FLUID WAS DRAINED FROM THE POCKET SITE. THE PT WAS SEEN AGAIN ON (B)(6) 2011 WHEN 590 MLS OF FLUID WAS DRAINED FROM THE POCKET. ON (B)(6) 2011, SURGERY WAS PERFORMED. THE INCISION WAS OPENED, AND THE SECTION OF THE PUMP CONNECTOR PROXIMAL TO THE PUMP WAS NOTED TO BE FRACTURED. CSF (CEREBROSPINAL FLUID) WAS COMING FROM THE CATHETER. APPROXIMATELY 450 MLS OF FLUIDS WAS DRAINED FROM THE POCKET. THERE WERE NO OBVIOUS SIGNS OF INFECTION. A NEW PUMP CONNECTOR WAS ATTACHED AND THE PUMP WAS PLACED INTO A MESH POUCH. THE POCKET WAS SECURED. FOLLOWING SURGERY, THE PUMP DOSE WAS REDUCED BY 85%. THE PT WAS ADMITTED TO THE HOSPITAL FOR 23-HOUR OBSERVATION. THE PT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 8835, LOT # NPG019094N| IMPLANTED:| CATHETER: MODEL 8709, LOT # L62218| CATHETER: MODEL 8578, LOT # N261164004| EXPLANTED:| IMPLANTED: