BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2667272 · Received July 24, 2012

    Report

    Report Number
    3007566237-2012-01736
    Event Type
    Injury
    Date Received
    July 24, 2012
    Date of Event
    February 9, 2012
    Report Date
    June 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, LOT#, SERIAL# UNKNOWN, 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS.

    Description of Event or Problem · 1

    LITERATURE: SERRA, G., MARCHIORETTO, F. OCCIPITAL NERVE STIMULATION FOR CHRONIC MIGRAINE: A RANDOMIZED TRIAL. PAIN PHYSICIAN. 2012; 15(3):245-253. SUMMARY: CHRONIC MIGRAINE (CM) AND MEDICATION OVERUSE HEADACHE (MOH) ARE DISABLING CONDITIONS THAT MAY BE ONLY PARTIALLY MANAGED WITH CONSERVATIVE TREATMENTS. OCCIPITAL NERVE STIMULATION (ONS) IS AN INNOVATIVE TREATMENT FOR HEADACHE DISORDERS. THE OBJECTIVE WAS TO INVESTIGATE THE SAFETY AND EFFICACY OF ONS FOR CM AND MOH PATIENTS AND TO EVALUATE CHANGES IN DISABILITY, QUALITY OF LIFE, AND DRUG INTAKE IN IMPLANTED PATIENTS. ELIGIBLE PATIENTS WHO RESPONDED TO A STIMULATION TRIAL UNDERWENT DEVICE IMPLANTATION AND WERE RANDOMIZED TO "STIMULATION ON" AND "STIMULATION OFF" ARMS. PATIENTS CROSSED OVER AFTER ONE MONTH, OR WHEN THEIR HEADACHES WORSENED. STIMULATION WAS THEN SWITCHED ON FOR ALL PATIENTS. DISABILITY AS MEASURED BY THE MIGRAINE DISABILITY ASSESSMENT (MIDAS), QUALITY OF LIFE (SF-36), AND DRUG INTAKE (PATIENT'S DIARY) WERE ASSESSED OVER A ONE-YEAR FOLLOW-UP. (B)(4). HEADACHE INTENSITY AND FREQUENCY WERE SIGNIFICANTLY LOWER IN THE ON ARM THAN IN THE OFF ARM (P <(><<)>(><(><<)><(><<)>)> 0.05) AND DECREASED FROM THE BASELINE TO EACH FOLLOW-UP VISIT IN ALL PATIENTS WITH STIMULATION ON (MEDIAN MIDAS A AND B SCORES: BASELINE = 70 AND 8; ONE-YEAR FOLLOW-UP = 14 AND 5, P <(><<)>(><(><<)><(><<)>)> 0.001). QUALITY OF LIFE SIGNIFICANTLY IMPROVED (P <(><<)>(><(><<)><(> <<)>)> 0.05) DURING THE STUDY. TRIPTANS AND NONSTEROIDAL ANTI-INFLAMMATORY DRUG USE FELL DRAMATICALLY FROM THE BASELINE (20 AND 25.5 DOSES/MONTH) TO EACH FOLLOW-UP VISIT (3 AND 2 DOSES/MONTH AT ONE YEAR, P <(><<)>(><(><<)><(><<)>)> 0.001). (B)(4). REPORTED EVENT: THREE PATIENTS SUFFERED LEAD DISLOCATIONS. TWO WERE CLASSIFIED AS "SEVERE" AND ONE AS "MILD." THE ELECTRODES WERE REPOSITIONED AND NO FURTHER COMPLICATIONS OCCURRED. ONE PATIENT DEVELOPED AN INFECTION AFTER THE TRIAL. THE PATIENT EXITED THE STUDY AND RECEIVED THE REQUIRED MEDICAL TREATMENT. ONE PATIENT DEVELOPED AN INFECTION AFTER THREE MONTHS AND WITHDREW FROM THE STUDY. THE PATIENT RECEIVED THE REQUIRED MEDICAL TREATMENT.

    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 00046 YR Required Intervention PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN