BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATION ELECTRODE

    MDR report key: 7375242 · Received March 27, 2018

    Report

    Report Number
    3007566237-2018-00899
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    January 5, 2018
    Report Date
    March 27, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ZSIGMOND, P., HEMM-ODE, S., WARDELL, K. OPTICAL MEASUREMENTS DURING DEEP BRAIN STIMULATION LEAD IMPLANTATION: SAFETY ASPECTS. STEREOTACT FUNCT NEUROSURG. 2018;95(6):392-399. DOI: 10.1159/000484944. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: BACKGROUND: INTRACEREBRAL HEMORRHAGE (ICH) IS THE MOST FEARED COMPLICATION IN DEEP BRAIN STIMULATION (DBS) SURGERY. THE AIM OF THE STUDY WAS TO EVALUATE PATIENT SAFETY AND OUTCOME USING LASER DOPPLER FLOWMETRY (LDF) AS GUIDANCE TOOL DURING DBS IMPLANTATIONS. METHODS: AN LDF PROBE ADAPTED FOR THE STEREOTACTIC SYSTEM WAS USED AS GUIDE FOR CREATION OF THE TRAJECTORY. THE MICROCIRCULATION ALONG 83 PREPLANNED TRAJECTORIES WAS MEASURED WITH THE GUIDE DURING DBS SURGERY FOR MOVEMENT DISORDERS. THE MICROVASCULAR BLOOD FLOW LEVELS WERE INVESTIGATED FOR ALL MEASUREMENT POSITIONS. MEDICAL RECORD AND POSTOPERATIVE RADIOLOGY WERE RETROSPECTIVELY REVIEWED. RESULTS: OF 2,963 MEASUREMENT POSITIONS, 234 (7.9%) SHOWED AT LEAST A DOUBLED BLOOD FLOW COMPARED TO THE SURROUNDING TISSUE. OF THESE 2.2% HAD A MORE THAN 5 TIMES HIGHER BLOOD FLOW IN FRONT OF THE PROBE TIP. ALONG 1 TRAJECTORY, A SMALL ICH WAS DETECTED DURING SURGERY. INCREASED BLOOD FLOW WAS MORE COMMON CLOSE TO SULCI AND VERTICALS. CONCLUSION: REAL-TIME LDF MEASUREMENT OF THE MICROCIRCULATION USING A FORWARD-LOOKING PROBE DURING DBS SURGERY CAN DETECT BLOOD FLOW PEAKS AND FURTHER MINIMIZE THE RISK OF DEVELOPING ICH. NO SEPARATE GUIDE TUBE IS NECESSARY AS THE PROBE ALSO CREATES THE TRAJECTORY FOR THE DBS LEAD. REPORTED EVENT: A PATIENT UNDERGOING IMPLANTATION OF A DEEP BRAIN STIMULATION (DBS) LEAD HAD THE STEREOTACTIC FRAME DETACH DURING THE SURGERY, SO THE SURGERY WAS ¿INHIBITED.¿ DURING THE SURGERY THEIR LASER DOPPLER FLOWMETRY (LDF) SYSTEM SHOWED AN ATYPICAL MEASUREMENT THAT WAS LATER CONFIRMED TO BE BLEEDING ON A POSTOPERATIVE CT SCAN, WHICH DISCOVERED A SMALL ASYMPTOMATIC INTRACRANIAL HEMORRHAGE ALONG THE TRAJECTORY OF THE LEAD. THE PATIENT ULTIMATELY RETURNED 3 MONTHS LATER FOR A NEW DBS SURGERY. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218841 UNKNOWN IMPLANTABLE NEUROSTIMULATION ELECTRODE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other