BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5172461 · Received October 24, 2015

    Report

    Report Number
    3007566237-2015-03071
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    July 15, 2015
    Report Date
    September 25, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE SERIAL/LOT NUMBERS OR PATIENT INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3986A, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    VALENTIN, A., UGHRATDAR, I., CHESEREM, B., MORRIS, R., SELWAY, R., ALARCON, G. EPILEPSIA PARTIALIS CONTINUA RESPONSIVE TO NEOCORTICAL ELECTRICAL STIMULATION. EPILEPSIA. 2015. 56 (8): E104-E109. DOI: 10.1111/EPI.13067. SUMMARY: EPILEPSIA PARTIALIS CONTINUA (EPC), DEFINED AS A SYNDROME OF CONTINUOUS FOCAL JERKING, IS A RARE FORM OF FOCAL STATUS EPILEPTICUS THAT USUALLY AFFECTS A DISTAL LIMB, AND WHEN PROLONGED, CAN PRODUCE LONG-LASTING DEFICITS IN LIMB FUNCTION. SUBSTANTIAL ELECTROPHYSIOLOGIC EVIDENCE LINKS THE ORIGIN OF EPC TO THE MOTOR CORTEX; THUS SURGICAL RESECTION CARRIES THE RISK OF SIGNIFICANT HANDICAP. WE PRESENT TWO PATIENTS WITH FOCAL, DRUG-RESISTANT EPC, WHO WERE ADMITTED FOR INTRACRANIAL VIDEO-ELECTROENCEPHALOGRAPHY MONITORING TO ELUCIDATE THE LOCATION OF THE EPILEPTOGENIC FOCUS AND IDENTIFICATION OF ELOQUENT MOTOR CORTEX WITH FUNCTIONAL MAPPING. IN BOTH CASES, THE FOCUS RESIDED AT OR NEAR ELOQUENT MOTOR CORTEX AND THEREFORE PRECLUDED RESECTIVE SURGERY. CHRONIC CORTICAL STIMULATION DELIVERED THROUGH SUBDURAL STRIPS AT THE SEIZURE FOCUS (CONTINUOUS STIMULATION AT 60-130 HZ, 2-3 MA) RESULTED IN >90% REDUCTION IN SEIZURES AND ABOLITION OF THE EPC AFTER A FOLLOW-UP OF 22 MONTHS IN BOTH PATIENTS. FOLLOWING PERMANENT IMPLANTATION OF CORTICAL STIMULATORS, NO ADVERSE EFFECTS WERE NOTED. EPC RESTARTED WHEN INTENSITY WAS REDUCED OR BATTERIES DEPLETED. BATTERY REPLACEMENT RESTORED PREVIOUS IMPROVEMENT. THIS TWO-CASE REPORT OPENS UP AVENUES FOR THE TREATMENT OF THIS DEBILITATING CONDITION. REPORTED EVENT: ONE (B)(6) MALE PATIENT UNDERWENT CHRONIC CORTICAL STIMULATION TO CONTROL SEIZURES. FOLLOWING IMPLANT, THE PATIENT REPORTED >90% IMPROVEMENT IN THE FREQUENCY OF SELF-LIMITED SEIZURES. AT 10 MONTHS, THE STIMULATOR BATTERY DEPLETED AND EPILEPSIA PARTIALIS CONTINUA (EPC) RESTARTED. THE PATIENT HAD SEVERAL EPISODES OF STATUS EPILEPTICUS WITH MOTOR SEIZURES FOLLOWED BY TONIC-CLONIC SEIZURES. AFTER REPLACEMENT OF THE BATTERY, EPC RESOLVED AND THE SELF-LIMITED SEIZURES WERE REDUCED BY >90%. THIS EFFECT WAS SUSTAINED AT 22 MONTH FOLLOW-UP. 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
    705297 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 37601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Other