BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1150398 · Received September 5, 2008

    Report

    Report Number
    2182207-2008-05469
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    March 1, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH INTERMITTENT SPASTICITY, WEIGHT LOSS AND WITHDRAWAL (SYMPTOMS NOT SPECIFIED). THE PATIENT HAD A VOLUME DISCREPANCY WITH APPROX 15% MORE DRUG IN THE PUMP THAN WAS EXPECTED (EXACT VOLUMES WERE NOT REPORTED). A ROLLER STUDY WAS PERFORMED, AND NO PROBLEMS WERE FOUND. THE PATIENT'S PROXIMAL CATHETER WAS REVISED AND A NEW PUMP CONNECTOR PLACED. THE PATIENT WAS FOUND TO HAVE SPINAL CORD COMPRESSION AND WAS REPORTED TO BE AWAITING CERVICAL SURGERY. THE PATIENT'S PUMP WAS ALSO REPOSITIONED. THE PATIENT'S PUMP CONTAINED HYDROMORPHONE 40 MG/ML, FENTANYL 200 MCG/ML, AND COMPOUNDED BACLOFEN 1000 MCG/ML. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT OCCURRED AS A RESULT OF A PATIENT ISSUE. THE PATIENT LOST OVER 100 POUNDS THE LAST 1 1/2 YEARS. REFERENCE MFR REPORT #6000030200801945.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| CATHETER MODEL 8709 LOT# J12250R14| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED