BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242960 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-07638
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    June 26, 2008
    Report Date
    October 25, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERSISTENT SPINAL HEADACHES AND EXTERNAL LEAKING OF CEREBROSPINAL FLUID TWO WEEKS FOLLOWING A PUMP AND CATHETER IMPLANT. AN EPIDURAL BLOOD PATCH WAS UNSUCCESSFUL IN RELIEVING THE PATIENT'S SYMPTOMS. THE CATHETER WAS FOUND TO BE INTACT WITH THE TIP AT THE C7 LEVEL AND NO LEAKING WAS NOTED. THE OLD SILK TIE WAS REMOVED AND TWO NEW SILK PURSESTRING SUTURES WERE USED TO TIGHTEN UP THE CATHETER AT THE SPINAL EXIT SITE. THE REPORT INDICATES THAT THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER HYDROMORPHONE 250UG/ML WITH A DAILY DOSE OF 199.87 UG. THE PUMP ALSO CONTAINED BUPIVICAINE 7.3 MG/ML AND DROPERIDOL 178UG/ML.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention PROGRAMMER: MODEL 8832| EXPLANTED| CATHETER: MODE 8709