BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6524535 · Received April 26, 2017

    Report

    Report Number
    3007566237-2017-01604
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    February 11, 2017
    Report Date
    April 26, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE: PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PT GENDER: PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KOCHANSKI RB, PAL G, BUS S, METMAN LV, SANI S. IMPROVING THE ACCURACY OF MICROELECTRODE RECORDING IN DEEP BRAIN STIMULATION SURGERY WITH INTRAOPERATIVE CT. JOURNAL OF CLINICAL NEUROSCIENCE (2017) DOI: 10.1016/J.JOCN.2017.02.037 ABSTRACT: MICROELECTRODE RECORDING (MER) IS USED TO CONFIRM ELECTROPHYSIOLOGICAL SIGNALS WITHIN INTENDED ANATOMIC TARGETS DURING DEE P BRAIN STIMULATION (DBS) SURGERY. WE DESCRIBE A NOVEL TECHNIQUE CALLED INTRAOPERATIVE CT-GUIDED EXTRAPOLATION (ICTE) TO PREDICT THE INTENDED MICROELECTRODE TRAJECTORY AND, IF NECESSARY, MAKE CORRECTIONS IN REAL-TIME BEFORE DURAL OPENING. PRIOR TO DURAL OPENING, A GUIDE TUBE WAS INSERTED THROUGH THE HEADSTAGE AND RESTED ON DURA. INTRAOPERATIVE CT (ICT) WAS OBTAINED, AND A TRAJECTORY WAS EXTRAPOLATED ALONG THE PATH OF THE GUIDE TUBE TO TARGET DEPTH USING TARGETING SOFTWARE. THE COORDINATES WERE RECORDED AND COMPARED TO INITIAL PLAN COORDINATES. IF NEEDED, ADJUSTMENTS WERE MADE USING THE HEADSTAGE TO CORRECT FOR ERROR. THE GUIDE TUBE WAS THEN INSERTED AND MER ENSUED. AT TARGET, ICT WAS PERFORMED AND MICROELECTRODE TIP COORDINATES WERE COMPARED WITH PLANNED/ADJUSTED TRACK COORDINATES. RADIAL ERROR BETWEEN MER TRACK AND PLANNED/ADJUSTED TRACK WAS CALCULATED. FOR COMPARISON, MER TRACK ERROR PRIOR TO THE ICTE TECHNIQUE WAS ASSESSED RETROSPECTIVELY IN PATIENTS WHO UNDERWENT MER USING ICT, WHEREBY ICT WAS PERFORMED FOLLOWING COMPLETION OF THE FIRST MER TRACK. FORTY-SEVEN MER TRACKS WERE ANALYZED PRIOR TO ICTE (PRE-ICTE), AND 90 TRACKS WERE PERFORMED USING THE ICTE TECHNIQUE. THERE WAS NO DIFFERENCE BETWEEN RADIAL ERROR OF PRE-ICTE MER TRACK AND PLANNED TRAJECTORY (2.1 ± 0.12 MM) COMPARED TO ICTE PREDICTED TRAJECTORY AND PLANNED TRAJECTORY (1.76 ± 0.13 MM, P > 0.05). ICTE WAS USED TO MAKE TRAJECTORY ADJUSTMENTS WHICH REDUCED RADIAL ERROR BETWEEN THE NEWLY CORRECTED AND FINAL MICROELECTRODE TIP COORDINATES TO 0.84 ± 0.08 MM (P <(><<)> 0.001). INTER-RATER RELIABILITY WAS ALSO TESTED USING A SECOND BLINDED MEASUREMENT REVIEWER WHICH SHOWED NO DIFFERENCE BETWEEN PREDICTED AND PLANNED MER TRACK ERROR (P = 0.53). ICTE CAN PREDICT AND REDUCE TRAJECTORY ERROR FOR MICROELECTRODE PLACEMENT COMPARED WITH THE TRADITIONAL USE OF ICT POST MER. REPORTED EVENT: ONE PATIENT WITH DEEP BRAIN STIMULATION (DBS) EXPERIENCED A POSTOPERATIVE COMPLICATION CONSISTING OF HARDWARE INFECTION REQUIRING EXPLANT OF THE ENTIRE DBS SYSTEM. THERE WAS NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306086 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention