BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 6149538 · Received December 6, 2016

    Report

    Report Number
    3007566237-2016-04288
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    October 18, 2016
    Report Date
    February 9, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-40, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW DETERMINED THAT THE MOST APPROPRIATE PATIENT CODE APPLICABLE TO THE REPORTED EVENT WAS (B)(4), INSTEAD OF (B)(4). SUPPLEMENTAL INITIATED TO NOTE THIS UPDATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR REPORTED THAT OF THE ADVERSE EVENTS MENTIONED IN THE ARTICLE NONE OF THEM RELATED DIRECTLY TO MEDTRONIC DEVICES OR PRODUCTS, BUT WERE INSTEAD RELATED TO THE SURGICAL PROCEDURE AND COMORBID RISK FACTORS IN PATIENTS.

    Description of Event or Problem · 1

    WANG, X., WANG, J., ZHAO, H., LI, N., GE, S., CHEN, L., LI, J., JING, J, SU, M., ZHENG, Z., ZHANG, J., GAO, G., WANG, X. CLINICAL ANALYSIS AND TREATMENT OF SYMPTOMATIC INTRACRANIAL HEMORRHAGE AFTER DEEP BRAIN STIMULATION SURGERY, BRITISH JOURNAL OF NEUROSURGERY. 2016. DOI: 10.1080/02688697.2016.1244252. SUMMARY: BACKGROUND: SYMPTOMATIC INTRACRANIAL HEMORRHAGE (ICH) MAY LEAD TO PERMANENT NEUROLOGICAL DISABILITY OF PATIENTS AND HAS IMPEDED THE EXTENSIVE CLINICAL APPLICATION OF DEEP BRAIN STIMULATION (DBS). THE PRESENT STUDY WAS CONDUCTED TO DISCUSS THE INCIDENCE, PREVENTION, AND TREATMENT OF SYMPTOMATIC ICH AFTER DBS SURGERY. METHODS: FROM JANUARY 2009 TO DECEMBER 2014, 396 PATIENTS UNDERWENT DBS WITH A TOTAL OF 691 IMPLANTED LEADS. IN ALL, 10 PATIENTS HAD SYMPTOMATIC ICH. WE ANALYZED THESE CASES¿ CLINICAL CHARACTERISTICS, INCLUDING COMORBID DIAGNOSES AND COAGULATION PROFILE. WE DESCRIBED THE ONSET OF ICH, IMAGING FEATURES, CLINICAL MANIFESTATIONS, TREATMENT, NEUROLOGICAL IMPAIRMENT, AND OUTCOME OF DBS. RESULTS: OF THE 10 PATIENTS WITH SYMPTOMATIC ICH, 2 HAD HYPERTENSION. THREE CASES OF ICH OCCURRED WITHIN 12 H OF THE PROCEDURE; FOUR CASES WITHIN 24 H. FIVE EXPERIENCED GRAND MAL SEIZURES CONCURRENTLY WITH HEMORRHAGE. UNILATERAL FRONTAL LOBE HEMORRHAGE OCCURRED IN ALL CASES. IN SEVEN CASES, HEMATOMAS OCCURRED AROUND THE ELECTRODES. SOME HEMATOMAS WERE NOT WELL-CIRCUMSCRIBED AND HAD PERIHEMATOMAL EDEMA. CONSERVATIVE THERAPY WAS ADMINISTERED TO 8 PATIENTS, AND 2 PATIENTS UNDERWENT CRANIOTOMY AND HEMATOMA EVACUATION. ALL ELECTRODES WERE SUCCESSFULLY PRESERVED. NEUROLOGICAL DYSFUNCTION IN ALL PATIENTS GRADUALLY IMPROVED. NINE PATIENTS ULTIMATELY EXPERIENCED EFFECTIVE SYMPTOM RELIEF OF PARKINSON¿S DISEASE WITH DBS. CONCLUSIONS: SYMPTOMATIC ICH SHOULD BE IDENTIFIED AS SOON AS POSSIBLE AFTER IMPLANTATION SURGERY AND TREATED EFFECTIVELY TO LIMIT NEUROLOGICAL DEFICIT AND PRESERVE DBS LEADS AS OF 78 MONTHS POST-IMPLANT. REPORTED EVENTS: 8. PATIENT 8: A (B)(6) FEMALE PATIENT WITH BILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) FOR PARKINSON'S DISEASE (PD) EXPERIENCED GRAND-MAL SEIZURES RELATED TO A POST-OPERATIVE INTRACRANIAL HEMORRHAGE WHICH WAS CONFIRMED BY CT-SCAN. ALL PATIENTS REPORTEDLY EXPERIENCED PERI-HEMATOMAL EDEMA. THE AUTHORS REPORTED THE 18 ML HEMORRHAGE OCCURRED IN THE RIGHT FRONTAL LOBE AND CEREBRAL PEDUNCLE AND DUE TO VASCULAR INJURY BY ADVANCING THE CANNULA. THE PATIENT WAS TREATED WITH CONSERVATIVE THERAPY AND INTRACRANIAL PRESSURE MONITORING, THE ELECTRODES WERE MAINTAINED, AND THE PATIENT ULTIMATELY RECEIVED EFFECTIVE THERAPY, HOWEVER THEY REPORTED SLIGHT DYSPHASIA AND HEMIPARESIS AS SEQUELAE AS OF 12 MONTHS POST-IMPLANT. THE AUTHORS STATED THAT 9 OUT OF 10 PATIENTS WERE IMPLANTED WITH 3389-40 ELECTRODES, AND THE 10TH HAD A PINS ELECTRODE, WHICH IS NOT MANUFACTURED BY MEDTRONIC. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT. AS SUCH IT REMAINS IMPOSSIBLE TO CONFIRM WHICH STUDY PATIENT WAS IMPLANTED WITH THE PINS ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798602 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other