BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 5364941 · Received January 13, 2016

    Report

    Report Number
    3007566237-2016-00256
    Event Type
    Injury
    Date Received
    January 13, 2016
    Report Date
    December 22, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_PUMP, LOT# UNKNOWN, PRODUCT TYPE: PUMP; PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER; PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    GARRAFFA, G., SCAGLIONE, V., FELICE, F., RICAPITO, R. SCINTIGRAPHIC FUNCTIONAL EVALUATION OF INTRATHECAL DRUG INFUSION DEVICES. EUROPEAN JOURNAL OF NUCLEAR MEDICINE AND MOLECULAR IMAGING. 2015;42(1):S315. DOI: 10.1007/S00259-015-3198-Z.. SUMMARY: MALFUNCTIONING OF THE INFUSION SYSTEM OR PROGRESSION OF PAIN DISEASE CAUSES INCREASING INFUSION RATES OR DRUG AMOUNT. ADMINISTRATION OF A NOT-ABSORBED RADIONUCLIDE (99MTC-DTPA) IN THE PUMP RESERVOIR AND SEQUENTIAL SCANNING ALLOW TO FOLLOW THE PROGRESSION OF THE RADIONUCLIDE ALONG THE CATHETER TO THE SPINE. THE IMAGES SHOW ANY INTERRUPTION/DELAY OF THE SYSTEM RADIONUCLIDE PROGRESSION AND, IF THE FLOW RATE OF THE PUMP DEVICE IS PROGRAMMABLE, QUANTITATIVE EVALUATION OF THE FLOW ITSELF ALONG SYSTEM. TO EVALUATE THE EFFECTIVENESS OF 99MTC-DPTA INFUSION WITHIN THE DEVICE IN ORDER TO DETECT MALFUNCTIONING AND TO CORRELATE THE RESULTS WITH PATIENT MANAGEMENT AND OUTCOME. REPORTED EVENTS: 1. PATIENT WITH FLOW REDUCTION PRESENTED PUMP FAILURE 2. 5 PATIENTS SHOWED INTERRUPTED PROGRESSION ALONG THE ABDOMINAL PORTION OF THE CATHETER. ABOUT 400 MBQ 99MTC-DPTA WAS INJECTED INTO THE PUMP RESERVOIR, THEN PLANAR SERIAL STATIC ABDOMINAL SCANS WERE PERFORMED EVERY THREE HOURS FOR 24 HOURS TO FOLLOW TRACER PROGRESSION. ONCE THE TRACER ARRIVED IN THE SPINAL LIQUORAL SYSTEM, WHOLE-BODY SCANS WERE PERFORMED. PATIENTS WITH FLOW STOP WERE RE-OPERATED AND OPERATIVE FINDINGS CONFIRMED THE SCINTIGRAPHIC DATA. 3. 1 PATIENT SHOWED INTERRUPTED PROGRESSION ALONG THE ABDOMINAL PORTION OF THE CATHETER WITH SUBCUTANEOUS DISPERSION OF THE RADIONUCLIDE. ABOUT 400 MBQ 99MTC-DPTA WAS INJECTED INTO THE PUMP RESERVOIR, THEN PLANAR SERIAL STATIC ABDOMINAL SCANS WERE PERFORMED EVERY THREE HOURS FOR 24 HOURS TO FOLLOW TRACER PROGRESSION. ONCE THE TRACER ARRIVED IN THE SPINAL LIQUORAL SYSTEM, WHOLE-BODY SCANS WERE PERFORMED. PATIENTS WITH FLOW STOP WERE RE-OPERATED AND OPERATIVE FINDINGS CONFIRMED THE SCINTIGRAPHIC DATA. 4. 1 PATIENT SHOWED QUANTITATIVE ALTERATION OF THE FLOW RATE, TOO SLOW RESPECT TO THE PROGRAMMED DELIVERY FLOW RATE. ABOUT 400 MBQ 99MTC-DPTA WAS INJECTED INTO THE PUMP RESERVOIR, THEN PLANAR SERIAL STATIC ABDOMINAL SCANS WERE PERFORMED EVERY THREE HOURS FOR 24 HOURS TO FOLLOW TRACER PROGRESSION. ONCE THE TRACER ARRIVED IN THE SPINAL LIQUORAL SYSTEM, WHOLE-BODY SCANS WERE PERFORMED. FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN THE CAUSE OF THE PUMP FAILURE, INTERRUPTED PROGRESSION ALONG THE ABDOMINAL PORTION OF THE CATHETER, AND QUANTITATIVE ALTERATION OF THE FLOW RATE, DIAGNOSTICS PERFORMED AND ACTIONS/INTERVENTIONS TAKEN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. MASTER FILE, NO RELATED PES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21279 INTRATHECAL CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention