BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE INFUSION PUMP

    MDR report key: 5360595 · Received January 12, 2016

    Report

    Report Number
    3007566237-2016-00208
    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 PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, PRODUCT TYPE: CATHETER. (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 4 IS (B)(6) YEAR-OLD MALE WITH HISTORY OF SPINAL CORD INJURY AND T8 SPASTIC PARAPLEGIA. THE PATIENT EXPERIENCED REDUCED ITB EFFECTIVENESS AND PRIOR CONVENTIONAL X-RAYS WERE NOT CONCLUSIVE. PLANAR SCINTIGRAPHIC ACQUISITIONS REVEALED RADIOACTIVITY IN THE CATHETER, ABRUPT END OUTSIDE THE SAS. SPECT/CT REVEALED NO ACTIVITY IN THE SAS, ABRUPT END AT L2-L3. THE PATIENT UNDERWENT SURGICAL REVISION; A CATHETER DISCONNECTION AT L3 WAS DISCOVERED. REPEAT PLANAR SCINTIGRAPHIC ACQUISITIONS REVEALED RADIOACTIVITY IN THE CATHETER, ABRUPT END OUTSIDE THE SAS. REPEAT SPECT/CT REVEALED NO ACTIVITY IN THE SAS, ABRUPT END NEXT TO THE SPINE WITH LEAKAGE BEHIND THE PUMP. THE PATIENT UNDERWENT A SECOND SURGICAL REVISION; A CATHETER FRACTURE AT THE INTERSPINOUS SPACE WAS DISCOVERED. FOLLOW-UP WAS BEING CONDUCTED FOR THE CAUSE OF THE LEAKAGE BEHIND THE PUMP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19302 IMPLANTABLE INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention