BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATO

    MDR report key: 4988086 · Received August 10, 2015

    Report

    Report Number
    3007566237-2015-02221
    Event Type
    Injury
    Date Received
    August 10, 2015
    Date of Event
    April 8, 2015
    Report Date
    July 16, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    HYAM, J. A., AKRAM, H., FOLTYNIE, T., LIMOUSIN, P., HARIZ, M., ZRINZO, L. WHAT YOU SEE IS WHAT YOU GET: LEAD LOCATION WITHIN DEEP BRAIN STRUCTURES IS ACCURATELY DEPICTED BY STEREOTACTIC MAGNETIC RESONANCE IMAGING. NEUROSURGERY. 2015; 0:1-8 DOI: 10.1227/NEU.0000000000000848 SUMMARY: MAGNETIC RESONANCE IMAGING (MRI)-VERIFIED DEEP BRAIN STIMULATION RELIES ON THE CORRECT INTERPRETATION OF STEREOTACTIC IMAGING DOCUMENTING LEAD LOCATION IN RELATION TO VISIBLE ANATOMIC TARGET. HOWEVER, IT HAS BEEN SUGGESTED THAT LOCAL SIGNAL DISTORTION FROM THE LEAD ITSELF RENDERS ITS DEPICTION ON MRI UNRELIABLE. TO COMPARE LEAD LOCATION ON STEREOTACTIC MRI WITH SUBSEQUENT LOCATION OF ITS BRAIN TRACK AFTER REMOVAL. PATIENTS UNDERWENT DEEP BRAIN STIMULATION WITH THE USE OF MRI-GUIDED AND MRI-VERIFIED LEKSELL FRAME APPROACH. INFECTION OR SUBOPTIMAL EFFICACY REQUIRED LEAD REMOVAL AND SUBSEQUENT REIMPLANTATION BY USING THE SAME TECHNIQUE. POSTIMPLANTATION STEREOTACTIC MR IMAGES WERE ANALYZED. LATERAL (X) AND ANTEROPOSTERIOR (Y) DISTANCES FROM MIDCOMMISSURAL POINT TO CENTER OF THE LEAD HYPOINTENSITY WERE RECORDED AT THE ANTERIOR COMMISSURE-POSTERIOR COMMISSURE PLANE (PALLIDAL ELECTRODE) OR Z = 24 (SUBTHALAMIC ELECTRODE). STEREOTACTIC MRI BEFORE THE SECOND PROCEDURE, X AND Y DISTANCES FROM THE CENTER OF THE VISIBLE LEAD TRACK HYPOINTENSITY TO MIDCOMMISSURAL POINT WERE INDEPENDENTLY RECORDED. VECTORIAL DISTANCE FROM CENTER OF THE LEAD HYPOINTENSITY TO THE CENTER OF ITS TRACK WAS CALCULATED. SIXTEEN ELECTRODE TRACKS WERE STUDIED IN 10 PATIENTS. MEAN DIFFERENCES BETWEEN LEAD ARTIFACT LOCATION AND LEAD TRACK LOCATION WERE: X COORDINATE 0.4 MM 6 0.2; Y COORDINATE 0.6 MM 6 0.3. MEAN VECTORIAL DISTANCE WAS 0.7 MM 6 0.2. STEREOTACTIC DISTANCE BETWEEN LEAD LOCATION AND SUBSEQUENT BRAIN TRACK LOCATION ON MRI WAS SMALL. THE MEAN DISCREPANCY WAS APPROXIMATELY HALF THE DEEP BRAIN STIMULATION LEAD WIDTH. THIS SUGGESTS THAT LEAD HYPOINTENSITY SEEN ON POSTIMPLANTATION MRI IS INDEED AN ACCURATE REPRESENTATION OF ITS REAL LOCATION WITHIN DEEP BRAIN STRUCTURES. REPORTED EVENT(S) 1. 7 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) EXPERIENCED INFECTION OR SKIN EROSION NECESSITATING LEAD REMOVAL FOLLOWED BY DELAYED ELECTRODE RE-IMPLANTATION. RE-IMPLANTATION WAS PERFORMED BY USING THE SAME MRI-GUIDED AND MRI-VERIFIED TECHNIQUE THAT WAS USED DURING THE INITIAL IMPLANT. 2. 3 PATIENTS WITH DBS EXPERIENCED SUBOPTIMAL CLINICAL EFFICACY NECESSITATING LEAD REMOVAL FOLLOWED BY DELAYED ELECTRODE RE-IMPLANTATION. RE-IMPLANTATION WAS PERFORMED BY USING THE SAME MRI-GUIDED AND MRI-VERIFIED TECHNIQUE THAT WAS USED DURING THE INITIAL IMPLANT. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521791 UNKNOWN IMPLANTABLE NEUROSTIMULATO STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention