BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8141842 · Received December 7, 2018

    Report

    Report Number
    3007566237-2018-03536
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    August 22, 2018
    Report Date
    December 7, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AGE OF PATIENT FOR EACH REPORTED 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. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KRUGER, M.T., COENEN, V.A., JENKNER, C., URBACH, H., EGGER, K., REINACHER, P.C. COMBINATION OF CT ANGIOGRAPHY AND MRI IN SURGICAL PLANNING OF DEEP BRAIN STIMULATION. DIAGNOSTIC NEURORADIOLOGY. 2018; 60: 1151-1158. DOI: 10.1007/S00234-018-2079-0. SUMMARY: FOR SAFE DEEP BRAIN STIMULATION (DBS) PLANNING, AN ACCURATE VISUALIZATION AND LOCALIZATION OF VESSELS IS MANDATORY. CONTRAST ENHANCE D (CE) MRI DEPICTS BOTH ARTERIES AND VEINS. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) DETECTS ARTERIES WITH HIGH GEOMETRIC ACCURACY. THE AUTHORS ROUTINELY COMBINE BOTH MODALITIES FOR DBS PLANNING. A TOTAL OF 222 TRAJECTORIES IN A CONSECUTIVE SERIES OF 113 PATIENTS WHO UNDERWENT DBS OPERATIONS WERE INCLUDED. IN ALL TRAJECTORIES, THE NUMBER OF VEINS AND ARTERIES IN A 10-MM DIAMETER AROUND THE PLANNED TRAJECTORY WERE COUNTED IN A CEMRI AND A CTA. IF A VESSEL WAS VISIBLE IN BOTH MODALITIES, THE DISTANCE WAS MEASURED. A TOTAL OF 370 VESSELS WERE COUNTED. TWO HUNDRED FORTY VESSELS (65%) WERE VISIBLE IN BOTH MODALITIES. WITH 134 OF THE VESSELS, THE AUTHORS DETECTED A DIFFERENCE OF THE VESSEL¿S LOCATION WITH AN AVERAGE DISTANCE OF 1.24 MM (SD 0.58). EIGHTY VESSELS (22%) WERE VISIBLE ONLY IN THE CEMRI, 50 VESSELS (13%) ONLY IN THE CTA. THE AUTHORS HAD FOUR BLEEDINGS (1.8% PER LEAD) OF WHICH ONE WAS SYMPTOMATIC (0.45%). THE MAJORITY OF VESSELS WERE VISIBLE IN BOTH MODALITIES; HOWEVER, IN MORE THAN HALF OF THESE CASES, THE LOCATION WAS NOT IDENTICAL. HERE, THE LOCATION IN THE CTA CAN BE REGARDED AS THE GROUND TRUTH. MOREOVER, BOTH THE CTA AND THE CEMRI DEPICTED VESSELS NOT SEEN IN THE OTHER IMAGING MODALITY. THE AUTHORS THEREFORE ASSUME THAT THE COMBINATION OF BOTH IMAGING MODALITIES FOR DBS... REPORTED EVENTS: A (B)(6) MALE PATIENT IMPLANTED WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE EXPERIENCED SMALL BILATERAL INTRACRANIAL HEMORRHAGE OBSERVED ON POSTOPERATIVE CT SCAN. THE BLEEDINGS HAD VOLUMES OF 1.81 CC AND 0.35 CC. THE STN WAS TARGETED WITH MICROELECTRODE RECORDING (MER). THE PATIENT DID NOT DEVELOP ANY NEUROLOGICAL DEFICITS. A (B)(6) MALE PATIENT IMPLANTED WITH BILATERAL STN-DBS FOR PARKINSON'S DISEASE EXPERIENCED MINIMAL UNILATERAL VENTRICULAR BLEEDING OBSERVED ON POSTOPERATIVE CT. THE STN WAS TARGETED VIA A POSTERIOR APPROACH WITHOUT PERFORMING MER. THE PATIENT DID NOT DEVELOP ANY NEUROLOGICAL DEFICITS. A (B)(6) MALE PATIENT IMPLANTED WITH BILATERAL STN-DBS FOR PARKINSON'S DISEASE EXPERIENCED UNILATERAL BLEEDING LOCALIZED IN THE RIGHT THALAMUS CLOSE TO THE LEAD OBSERVED ON POSTOPERATIVE CT. THE BLEEDING HAD A VOLUME OF 1.36 CC. MICROELECTRODE RECORDING WAS PERFORMED DURING IMPLANT. THE PATIENT PRESENTED WITH CONFUSION AND DISORIENTATION IMMEDIATELY AFTER SURGERY. THE SYMPTOMS IMPROVED OVER THE COURSE OF THE NEXT FEW DAYS AND HE WAS DISCHARGED AFTER 14 DAYS WITH ONLY MILD SYMPTOMS. DURING OUT-PATIENT VISIT 3 MONTHS LATER, THE PATIENT HAD FULLY RECOVERED WITH NO VISIBLE HEMATOMA ON CT SCAN. NO DEVICE SPECIFICS COULD BE DETERMINED FROM THE REPORTED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983898 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other