BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4206419 · Received October 28, 2014

    Report

    Report Number
    3007566237-2014-03138
    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
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 PRODUCTS: PRODUCT ID 3487A, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE EXTENSION. (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: ONE 65-YEAR-OLD FEMALE PATIENT DID NOT EXPERIENCE AN IMPROVEMENT IN PAIN INTENSITY OR QUALITY OF LIFE. THE PATIENT¿S PRE-IMPLANT AND POST-IMPLANT PAIN INTENSITY SCORE WAS 5.0. THE PATIENT¿S PRE-IMPLANT AND POST-IMPLANT QUALITY OF LIFE SCORE WAS 5.0. THE REPORTER STATED THAT THIS PATIENT DID NOT EXPERIENCE MIGRAINE REDUCTION. AFTER INITIAL POST-IMPLANT IMPROVEMENT OF CHRONIC MIGRAINE PAIN, THE PATIENT DEVELOPED A TRIGEMINAL NEURALGIA DUE TO A NEUROVASCULAR CONFLICT AT THE CEREBELLOPONTINE ANGLE. PAIN RESOLVED AFTER NEUROSURGICAL MICROVASCULAR DECOMPRESSION, WHICH WAS PERFORMED IN APRIL 2012. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: RESTORE ULTRA INS MODEL 37712 AND PISCES QUAD LEAD MODEL 3487A 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
    690021 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention