BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2547124 · Received April 24, 2012

    Report

    Report Number
    3007566237-2012-00877
    Event Type
    Injury
    Date Received
    April 24, 2012
    Date of Event
    May 6, 2011
    Report Date
    April 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION: IMPLANTED: EXPLANTED: PRODUCT TYP LEAD. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: POURATAIN, N., REAMES, D.L., FRYSINGER, R,. ELIAS, W.J., COMPREHENSIVE ANALYSIS OF RISK FACTORS FOR SEIZURES AFTER DEEP BRAIN STIMULATION SURGERY, JOURNAL OF NEUROSURGERY, VOLUME 115 (2011). DOI: 10.3171/2011.4.JNS102075. SUMMARY: THE AIM OF THIS STUDY WAS TO ASSESS RISK FACTORS FOR POSTOPERATIVE SEIZURES AFTER DEEP BRAIN STIMULATION (DBS) LEAD IMPLANTATION SURGERY AND THE IMPACT OF SUCH SEIZURES ON LENGTH OF STAY AND DISCHARGE DISPOSITION. THE AUTHORS REVIEWED A CONSECUTIVE SERIES OF 161 CASES INVOLVING PATIENTS WHO UNDERWENT IMPLANTATION OF 288 ELECTRODES FOR TREATMENT OF MOVEMENT DISORDERS AT A SINGLE INSTITUTION TO DETERMINE THE ABSOLUTE RISK OF POSTOPERATIVE SEIZURES, TO DESCRIBE THE TIMING AND TYPE OF SEIZURES, TO IDENTIFY STATISTICALLY SIGNIFICANT RISK FACTORS FOR SEIZURES, AND TO DETERMINE WHETHER THERE ARE POSSIBLE INDICATIONS FOR SEIZURE PROPHYLAXIS AFTER DBS LEAD IMPLANTATION. THE ELECTRONIC MEDICAL RECORDS WERE REVIEWED TO IDENTIFY DEMOGRAPHIC DETAILS, MEDICAL HISTORY, OPERATIVE COURSE, AND POSTOPERATIVE OUTCOMES AND COMPLICATIONS. TO EVALUATE SIGNIFICANT ASSOCIATIONS BETWEEN POTENTIAL RISK FACTORS AND POSTOPERATIVE SEIZURES, BOTH UNIVARIATE AND MULTIVARIATE ANALYSES WERE PERFORMED. SEVEN (4.3%) OF 161 PATIENTS EXPERIENCED POSTOPERATIVE SEIZURES, ALL OF WHICH WERE DOCUMENTED TO HAVE BEEN GENERALIZED TONIC-CLONIC SEIZURES. IN 5 (71%) OF 7 CASES, PATIENTS ONLY EXPERIENCED A SINGLE SEIZURE. SIMILARLY, IN 5 OF 7 CASES, PATIENTS EXPERIENCED SEIZURES WITHIN 24 HOURS OF SURGERY. IN 6 (86%) OF THE 7 CASES, SEIZURES OCCURRED WITHIN 48 HOURS OF SURGERY. THESE RESULTS AFFIRM THAT SEIZURES ARE AN UNCOMMON COMPLICATION OF DBS SURGERY AND GENERALLY OCCUR WITHIN 48 HOURS OF SURGERY. THE RESULTS ALSO INDICATE THAT HEMORRHAGE, EDEMA, OR ISCHEMIA ON POSTOPERATIVE IMAGES ("ABNORMAL" IMAGING FINDINGS) INCREASES THE RELATIVE RISK OF POSTOPERATIVE SEIZURES BY 30- TO 50-FOLD, PROVIDING STATISTICAL CREDENCE TO THE LONG-HELD ASSUMPTION THAT SEIZURES ARE ASSOCIATED WITH INTRACRANIAL VASCULAR EVENTS. IN ALL CASES, THE IMPLANTABLE PULSE GENERATOR HAD NOT YET BEEN TURNED ON. REPORTED EVENTS: PATIENT 2 HAD 1 SEIZURE 1 DAY POST-IMPLANT. THE PATIENT WAS TREATED WITH PHENYTOIN FOR 2 WEEKS. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention