BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8410696 · Received March 11, 2019

    Report

    Report Number
    3007566237-2019-00584
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    January 1, 2019
    Report Date
    March 11, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. WHITING, AC., CATAPANO, JS., WALKER, CT., GODZIK, J., LAMBERT, M., PONCE, FA. PERI-LEAD EDEMA AFTER DEEP BRAIN STIMULATION SURGERY: A POORLY UNDERSTOOD BUT FREQUENT COMPLICATION. WORLD NEUROSURG. 2018. DOI: 10.1016/J.WNEU.2018.12.092. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: OBJECTIVE: POSTOPERATIVE PERI-LEAD EDEMA (PLE) IS A POORLY UNDERSTOOD COMPLICATION OF DEEP BRAIN STIMULATION (DBS), WHICH HAS BEEN DESCRIBED SPORADICALLY IN PATIENTS PRESENTING WITH PROFOUND AND OFTEN DELAYED SYMPTOMS. WE PERFORMED A PROSPECTIVE EVALUATION OF PATIENTS UNDERGOING DBS TO DETERMINE THE FREQUENCY OF AND IDENTIFY RISK FACTORS FOR PLE. METHODS: PATIENTS UNDERWENT DBS ELECTRODE PLACEMENT BY A SINGLE PHYSICIAN. POSTOPERATIVE MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED APPROXIMATELY 6 WEEKS AFTER THE OPERATION IN ASYMPTOMATIC SUBJECTS AND ANALYZED FOR PRESENCE OF PLE. ALL SYMPTOMATIC SUBJECTS UNDERWENT MRI AT THE TIME OF PRESENTATION. DATA REGARDING INDEX DISEASE, PREOPERATIVE MEDICAL ISSUES, OPERATIVE TECHNIQUE, AND INTRAOPERATIVE VARIABLES WERE COLLECTED AND STATISTICALLY ANALYZED. - RESULTS: A TOTAL OF 191 LEADS WERE PLACED IN 102 SUBJECTS; 15 PATIENTS (14.7%) DEMONSTRATED PLE. SEVEN PATIENTS (6.9%) PRESENTED WITH SYMPTOMS RELATED TO PLE, MOST OFTEN ALTERED MENTAL STATUS OR NEUROLOGIC DEFICIT. MANY OF THE MRI FINDINGS WERE PROFOUND, WITH PLE SOMETIMES SEVERAL CENTIMETERS IN DIAMETER. NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN PLE-POSITIVE AND NORMAL SUBJECTS WHEN ANALYZING MULTIPLE VARIABLES, INCLUDING PRESENCE OF VASCULAR DISEASE, HYPERTENSION, ANTICOAGULANT /ANTIPLATELET USE, ELECTRODE TARGET, INDEX DISEASE, UNILATERAL VERSUS BILATERAL LEAD PLACEMENT, NUMBER OF BRAIN PENETRATIONS, AND PRESENCE OR ABSENCE OF MICROELECTRODE RECORDING. - CONCLUSIONS: PATIENTS WITH POSTOPERATIVE PLE CAN PRESENT WITH SEVERE SYMPTOMS OR CAN BE ASYMPTOMATIC AND GO UNDIAGNOSED. BECAUSE OF THE DELAYED-ONSET POTENTIAL, PLE MAY BE MORE COMMON THAN PREVIOUSLY REPORTED. NO CLEAR RISK FACTORS HAVE BEEN IDENTIFIED; THEREFORE, FURTHER STUDIES AND INCREASED CLINICAL VIGILANCE ARE PARAMOUNT FOR IMPROVING COMPREHENSION AND POSSIBLE PREVENTION OF PLE. REPORTED EVENTS: PATIENT 14: A (B)(6)-YEAR-OLD MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR ESSENTIAL TREMOR (ET) EXPERIENCED PERI-LEAD EDEMA BASED ON POSTOPERATIVE IMAGING THAT WAS ASSOCIATED WITH TRANSIENT HEMIPARESIS. 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
    200003 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other