BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRATHECAL CATHETER

    MDR report key: 5360163 · Received January 12, 2016

    Report

    Report Number
    3007566237-2016-00194
    Event Type
    Injury
    Date Received
    January 12, 2016
    Report Date
    December 17, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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, PRODUCT TYPE: PUMP. (B)(4).

    Description of Event or Problem · 1

    FREMONDIERE, F., LACOEUILLE, F., SHER, A., COUTURIER, O., MENEI, P., RICHARD, I.,DINOMAIS, M. ISOTOPIC SCINTIGRAPHY COUPLED WITH COMPUTED TOMOGRAPHY FOR THE INVESTIGATION OF INTRATHECAL BACLOFEN DEVICE MALFUNCTION. ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION. 2015. DOI: 10.1016/J.APMR.2015.10.101. SUMMARY: TO ASSESS THE POTENTIAL USE OF INDIUM111 DIETHYLENETRIAMINE PENTA-ACETIC ACID (111IN-DTPA) SCINTIGRAPHY COUPLED WITH COMPUTED TOMOGRAPHY (CT) FOR THE INVESTIGATION OF ITB (INTRATHECAL BACLOFEN) DEVICE MALFUNCTION. THE COMBINATION OF SCINTIGRAPHY AND CT PROVIDES SIMULTANEOUS FUNCTIONAL AND ANATOMIC IMAGERY OF THE DEVICE. THE SLOW INFUSION OF THE RADIOISOTOPE MIMICS THE DIFFUSION OF BACLOFEN AND THIS COULD BE A USEFUL METHOD TO EXPLORE INTRATHECAL DEVICE MALFUNCTION. FURTHER STUDIES ARE REQUIRED TO COMPARE SCINTIGRAPHY COUPLED WITH CT AND RADIOPAQUE INJECTION FOLLOWED BY FLUOROSCOPY OR CT. REPORTED EVENTS: PATIENT 1 IS A (B)(6) FEMALE WITH HISTORY OF MULTIPLE SCLEROSIS AND SPASTIC PARAPARESIS. THE PATIENT EXPERIENCED REDUCED ITB EFFECTIVENESS AND PRIOR CONVENTIONAL X-RAYS WERE NOT CONCLUSIVE. PLANAR SCINTIGRAPHIC ACQUISITIONS REVEALED RADIOACTIVITY IN THE SAS AT THE SACRAL LEVEL, LOW ACTIVITY IN THE THORACIC AND CEREBRAL LEVEL. THERE WAS STAGNATION OF THE RADIOISOTOPE AT L5-S1. SPECT/CT REVEALED THAT THE DISTAL END OF THE CATHETER WAS WELL LOCATED IN THE SAS. SURGERY CONFIRMED THE CAUDAL ORIENTATION OF THE DISTAL CATHETER. THE PATIENT UNDERWENT REPLACEMENT OF THE CATHETER WITH CRANIAL ORIENTATION. FOLLOW-UP WAS BEING CONDUCTED FOR CLARIFICATION OF THE CATHETER MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18246 INTRATHECAL CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_CATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention