BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3449815 · Received November 5, 2013

    Report

    Report Number
    3007566237-2013-03584
    Event Type
    Injury
    Date Received
    November 5, 2013
    Date of Event
    June 20, 2013
    Report Date
    October 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    TEODORCZYK, J,. SZMUDA, T., SIEMINSKI, M., LASS, P., STONIEWSKI, P. ET.AL. EVALUATION OF USEFULNESS OF SCINTIGRAPHIC IMAGING IN DIAGNOSIS OF INTRATHECAL DRUG DELIVERY SYSTEM MALFUNCTION - A PRELIMINARY REPORT. POLISH JOURNAL OF RADIOLOGY. 2013. 78(3) SUMMARY/REPORTED EVENT: THIS REPORT REFERS TO A (B)(6) MALE PATIENT. INTRATHECAL BACLOFEN (ITB) SYSTEM IMPLANTED 5 YEARS EARLIER (SYNCHROMED I 20 ML - MEDTRONIC, (B)(4)). THE PATIENT RECEIVED BACLOFEN INTRATHECAL (MANUFACTURER UNKNOWN) FOR SPASTIC PARAPARESIS OF UNKNOWN ETIOLOGY AT AN UNKNOWN DATE AND DOSE. GRADUAL REDUCTION OF THERAPEUTIC EFFECT OF INTRATHECAL BACLOFEN WAS OBSERVED FOR 2 YEARS. SCINTIGRAPHY SHOWED HIGH ACTIVITY OF TRACER IN BODY FLUIDS, NO TRACER IN SPINAL CANAL. DUE TO HIGH SENSITIVITY OF SCINTIGRAPHY, APPEARANCE OF CONSIDERABLE RADIOTRACER AMOUNT IN BLOOD, SOFT TISSUES AND URINARY BLADDER WAS CHARACTERISTIC FOR A LEAK (NO NEED TO SEE POOLING OF RADIOTRACER NEAR LEAKAGE PLACE). CATHETER SYSTEM IN THIS PATIENT WAS LATER REPAIRED INTRAOPERATIVELY. AUTHOR CONCLUDED THAT RADIOLOGIC ASSESSMENT OF INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS) SYSTEM WAS ESSENTIAL. IT FACILITATES FINAL DIAGNOSIS IN MANY CASES, WAS BROADLY AVAILABLE AND CARRIES BASIC MORPHOLOGIC INFORMATION NEEDED FOR INTERPRETATION OF FUNCTIONAL RADIOISOTOPIC STUDIES OR LATER SURGICAL INTERVENTION. SCINTIGRAPHIC IMAGING SEEMED TO BE A VALUABLE FUNCTIONAL ADJUNCT TO FIRST-LINE MORPHOLOGICAL STUDIES ENABLING FINAL DIAGNOSIS IN MANY PATIENTS WITH POTENTIAL MALFUNCTION OF INTRATHECAL DRUG DELIVERY SYSTEMS (IDDS). FURTHER STUDIES ENCOMPASSING HIGHER NUMBER OF PATIENTS WERE NECESSARY TO DEFINE THE EXACT DIAGNOSTIC ACCURACY. SEE LITERATURE ARTICLE ATTACHED TO MANUFACTURER REPORT 3007566237-2013-03582.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569324 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention