BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4206616 · Received October 28, 2014

    Report

    Report Number
    3007566237-2014-03140
    Event Type
    Injury
    Date Received
    October 28, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE 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 AS IT WAS USED TO TREAT CHRONIC MIGRAINE. CONCOMITANT: PRODUCT ID 3487A, PRODUCT TYPE LEAD. PRODUCT ID 3487A, LOT# UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, (B)(4).

    Description of Event or Problem · 1

    DE AGOSTINO, R., FEDERSPIEL, B., CESNULIS, E., SANDOR, P.S. HIGH-CERVICAL SPINAL CORD STIMULATION FOR MEDICALLY INTRACTABLE CHRONIC MIGRAINE. NEUROMODULATION. 2014. DOI: 10.1111/NER.12236. SUMMARY: HIGH-CERVICAL SPINAL CORD STIMULATION (SCS) IS A PROMISING NEUROSTIMULATION METHOD FOR THE CONTROL OF CHRONIC PAIN, INCLUDING CHRONIC CLUSTER HEADACHE. THE EFFECTS OF HIGH-CERVICAL SCS IN PATIENTS WITH INTRACTABLE CHRONIC MIGRAINE PAIN ARE UNKNOWN. THIS STUDY IS A RETROSPECTIVE SURVEY OF A COHORT OF 17 CONSECUTIVE PATIENTS WITH MEDICALLY INTRACTABLE CHRONIC MIGRAINE PAIN IMPLANTED WITH A HIGH-CERVICAL SCS DEVICE BETWEEN 2007 AND 2011. AFTER A MEDIAN OF 15 MONTHS (RANGE 2¿48) SINCE IMPLANTATION, MEAN PAIN INTENSITY WAS SIGNIFICANTLY REDUCED BY 60% (P <(><<)> 0.0001), WITH 71% OF THE PATIENTS EXPERIENCING A DECREASE OF 50% OR MORE. THE MEDIAN NUMBER OF DAYS WITH MIGRAINE DECREASED FROM 28 (RANGE 12¿28) TO 9.0 (RANGE 0¿28) DAYS (P = 0.0313). QUALITY OF LIFE WAS SIGNIFICANTLY IMPROVED (P = 0.0006), AND THE PROPORTION OF PATIENTS NOT REQUIRING PAIN MEDICATION INCREASED FROM 0.0% TO 37.5% (P = 0.0313). USE OF PHARMACOLOGICAL AND NONPHARMACOLOGICAL TREATMENTS OF MIGRAINE WAS DECREASED. WORKING CAPACITY WAS NOT SIGNIFICANTLY IMPROVED. COMPLICATIONS WERE INFREQUENT: THREE INFECTIONS (13.0% OF ALL IMPLANTED) AND THREE LEAD DISLOCATIONS (17.6% OF ALL INCLUDED). IN PATIENTS WITH INTRACTABLE CHRONIC MIGRAINE TREATED WITH HIGH-CERVICAL SCS, PAIN AND QUALITY OF LIFE SIGNIFICANTLY IMPROVED, WARRANTING FURTHER RESEARCH. REPORTED EVENTS: 1. 3 PATIENTS EXPERIENCED INTERCURRENT INFECTIONS WHICH REQUIRED DEVICE EXPLANT; 2 PATIENTS EXPERIENCED LEAD DISLOCATIONS REQUIRING REPOSITIONING WITHIN THREE MONTHS POST-IMPLANT, 1 PATIENT EXPERIENCED LEAD DISLOCATION REQUIRING REPOSITIONING DURING THE TEST PHASE. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: RESTOREULTRA INS (10 PATIENTS), RESTOREADVANCE INS (3 PATIENTS), PRIMEADVANCED INS (4 PATIENTS) AND PISCES QUAD LEADS 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
    688923 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention