BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3449709 · Received November 5, 2013

    Report

    Report Number
    3007566237-2013-03582
    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 PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL # UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    TEODORCZYK, J., SZMUDA, T., SIEMINSKI, M., LASS, P., STONIEWSKI, P. 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: SCINTIGRAPHIC STUDIES WERE PERFORMED IN SELECTED PATIENTS WITH NEUROLOGICAL DISEASES ASSOCIATED WITH SPASTICITY, WHO HAD IDDS SYSTEM IMPLANTED AND WERE UNABLE TO MAINTAIN SATISFYING CLINICAL EFFECT OF INTRATHECALLY INFUSED BACLOFEN. AFTER EMPTYING THE IDDS SYSTEM OF THE DRUG, RADIOTRACER (99MTC-DTPA) SOLUTION WAS INJECTED INTO THE PUMP RESERVOIR. SUBSEQUENTLY, A SERIES OF SCINTIGRAPHIC IMAGES WAS REGISTERED, DEMONSTRATING PASSAGE AND DISTRIBUTION OF THE INFUSED RADIOTRACER. IN ALL INVESTIGATED CASES, SCINTIGRAPHIC STUDY RESULTED IN ACQUIRING RELEVANT ADDITIONAL DIAGNOSTIC INFORMATION. NORMAL OR DISRUPTED DISTRIBUTION OF RADIOTRACER IN SPINAL CANAL ALLOWED FOR A DIAGNOSIS DRUG RESISTANCE OR DEMONSTRATED PRESENCE OF ARACHNOID ADHESIONS RESPECTIVELY. EARLY APPEARANCE OF RADIOTRACER IN BLOOD WAS CONSIDERED A PROOF OF LEAK. OUR EXAMINATIONS HAD DECISIVE INFLUENCE ON FURTHER PATIENT TREATMENT, ALLOWING FOR DIAGNOSIS OF DRUG RESISTANCE IN ONE PATIENT OR COMPLICATION RELATED TO IDDS SYSTEM IN THREE OTHER CASES INCLUDING BREAKAGE OF A CATHETER, PUMP MALFUNCTION AND ARACHNOID ADHESIONS. SCINTIGRAPHIC METHODS CARRY SIGNIFICANT AMOUNT OF INFORMATION FACILITATING FINAL DIAGNOSIS OF THE CAUSE OF IDDS THERAPY FAILURE. THEY SHOULD BECOME AN IMPORTANT ELEMENT COMPLEMENTING THE DIAGNOSTIC STRATEGY IN PATIENTS WITH SUSPECTED FAILURE OF INTRATHECAL DRUG ADMINISTRATION SYSTEMS. INTERPRETATION OF RADIOISOTOPIC STUDIES, SINCE THEY ARE PURELY FUNCTIONAL, MUST BE PERFORMED IN STRICT RELATION TO CLINICAL DATA AND REPORTED EVENT: THIS REPORT REFERS TO A (B)(6) FEMALE PATIENT. INTRATHECAL BACLOFEN (ITB) (SYNCHROMED II 20 ML - MEDTRONIC, (B)(4)) WAS IMPLANTED 3 YEARS BEFORE. THE PATIENT RECEIVED INTRATHECAL BACLOFEN (MANUFACTURER UNKNOWN) FOR TREATMENT OF SPASTIC HEMIDYSTONIA. THE PATIENT HAD BEEN COMPLAINING OF DETERIORATION OF THERAPEUTIC EFFECT FOR A YEAR. SCINTIGRAPHY DEMONSTRATES NORMAL DISTRIBUTION OF RADIOTRACER IN A CATHETER SYSTEM, NO SIGNS OF LEAKAGE OR OBSTRUCTION, DISTINCT POOLING OF RADIOTRACER AT THE SITE OF INTRATHECAL CATHETER ORIFICE IN THE VERTEBRAL CANAL AS WELL AS FREE DISTRIBUTION OF RADIOTRACER IN CEREBROSPINAL FLUID. POOLING OF RADIOTRACER NEAR CATHETER ORIFICE SUGGESTED LOCAL OUTFLOW RESTRICTION. FINALLY, ARACHNOID ADHESIONS IN THE CATHETER TIP REGION WAS DIAGNOSED AND CONFIRMED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568830 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention