BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2655300 · Received July 13, 2012

    Report

    Report Number
    3007566237-2012-01646
    Event Type
    Injury
    Date Received
    July 13, 2012
    Date of Event
    December 1, 2011
    Report Date
    June 20, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, 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: ABEJON, D, CALVO, R., ARRANZ, J., PEREZ-CAJARAVILLE, J., DEL SAZ, J., AGUIERRE-JAIME, A. PERIPHERAL NERVE STIMULATION IN THE TREATMENT OF VARIOUS TYPES OF HEADACHE. REV ESP ANESTESIOL REANIM. 2011; 58(10):589-594. SUMMARY: HEADACHE HAS A GREAT IMPACT ON PATIENTS' QUALITY OF LIFE AND IN INDUSTRIALIZED COUNTRIES THERE IS ECONOMIC IMPACT AS WELL. ONCE OF THE PATHOPHYSIOLOGIC THEORIES TO EXPLAIN HEADACHE IS ACTIVATION OF AFFERENT C2-C3 NERVE FIBERS. AFFERENT PERIPHERAL NERVE STIMULATION BY OCCIPITAL NERVE PROVOCATION AT C2-C3 SEEMS TO ALLEVIATE HEADACHE BY ACTING ON THE TRIGEMINOCERVICAL COMPLEX, WHICH WOULD LARGELY EXPLAIN THE EFFECTIVENESS OF THIS MODALITY. THE AIM OF THIS STUDY WAS TO DESCRIBE PERIPHERAL NERVE STIMULATION AS AN ALTERNATIVE THERAPY IN PATIENTS WHO DO NOT RESPOND TO OTHER HEADACHE TREATMENTS. MULTICENTER RETROSPECTIVE STUDY BETWEEN APRIL 2005 AND MAY 2009, ANALYZING CASES OF PATIENTS TREATED WITH NERVE STIMULATION FOR SEVERE CHRONIC HEADACHE. IN ALL PATIENTS, THE MEDICAL HISTORY INCLUDED TYPE OF HEADACHE, INTENSITY OF PAIN ON A NUMERICAL SCALE, MEDICAL TREATMENT USED, AND NUMBER OF HEADACHE EPISODES. WE RECORDED THE PERCENTAGE OF PATIENTS WITH NEGATIVE TESTS. PATIENTS IMPLANTED WITH GENERATOR ASSESSED EFFECTIVENESS ON THE NUMERICAL SCALE; WE ANALYZED THE PERCENTAGE OF PERCEIVED IMPROVEMENT AT 1, 3, 6, AND 12 MONTHS. WE ALSO ANALYZED THE EXTENT OF COVERAGE PROVIDED BY THE ELECTRODES, PATIENT SATISFACTION, REDUCTION IN THE NUMBER OF EPISODES AND MEDICATION, AND COMPLICATIONS. OF 31 PATIENTS, 87% HAD POSITIVE RESULTS, WITH A SIGNIFICANT DECREASE IN PAIN FROM BASELINE (P <(><<)>(><(><<)><(><<)>)>0.001); 85.2% REPORTED SUSTAINED IMPROVEMENT OF >50%, AND 96.3% REPORTED A DECREASE OF >2 POINTS ON THE PAIN SCALE. ALL PATIENTS EXPRESSED SATISFACTION DURING THE PERIOD OF FOLLOW-UP. FIFTY-SIX PERCENT HAD NO HEADACHES AFTER A YEAR AND 47% HAD STOPPED TAKING MEDICATION. THE MOST FREQUENT COMPLICATION WAS ELECTRODE MIGRATION. REPORTED EVENTS: 4 ELECTRODE MIGRATIONS THAT REQUIRED SURGERY TO REPOSITION THE ELECTRODES. TWO PATIENT EXPERIENCED PAIN AT THE POCKET SITE WHICH REQUIRED SURGICAL REPOSITIONING. THREE INSTANCES OF DECUBITUS OR WOUND DEHISCENCE. ONE CASE OF LEAD INFECTION, REQUIRING EXPLANT. 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, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention