BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1180191 · Received September 29, 2008

    Report

    Report Number
    2182207-2008-06181
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 29, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE PUMP IMPLANT, THE PT EXPERIENCED "LEAKING SPINAL FLUID" FROM THE CATHETER INCISION SITE, A "SPINAL HEADACHE", DEVELOPMENT OF SEROMAS AT CATHETER AND PUMP INCISION SITES, "VISION PROBLEMS", AND "NO PAIN RELIEF". THE CATHETER INCISION SITE "DID NOT CLOSE PROPERLY" SO SPINAL FLUID LEAKED FROM THE SITE CAUSING SPINAL HEADACHES. A BLOOD PATCH PROCEDURE WAS PERFORMED TO CLOSE THE CATHETER INCISION SITE. THIS RESOLVED THE SPINAL FLUID LEAK AND SPINAL HEADACHES. THE PT THEN DEVELOPED A SEROMA AT THE CATHETER INCISION SITE FOLLOWED BY A SEROMA AT THE PUMP INCISION SITE. THE SEROMA AT THE PUMP INCISION SITE WAS DRAINED, BUT FILLED AGAIN BY THE END OF THE DAY. THE UNSPECIFIED 'VISION PROBLEM' CAUSED THE PT TO HAVE DIFFICULTY SEEING, HOWEVER, IT WAS NOTED THAT THERE IS A PRE-EXISTING HISTORY OF MIGRAINE HEADACHES WITH ACCOMPANIED VISION PROBLEMS. THE DRUG IN THE PUMP WAS PRIALT. INITIAL DOSING WAS 2.0 MCG/DAY AND WAS INCREASED OVER A MONTH TO 9.5 MCG/DAY. CONCOMITANT MEDICATION INCLUDES TRAZODONE. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709SC LOT# N165030025| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED