BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9872309 · Received March 24, 2020

    Report

    Report Number
    2182207-2020-00056
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    March 17, 2019
    Report Date
    March 24, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)_LIT.PDF].

    Description of Event or Problem · 1

    BELVIS R, RODRIGUEZ R, GUASCH M, ALVAREZ MJ, MOLET J, ROIG C. EFFICACY AND SAFETY OF SURGICAL TREATMENT OF CLUSTER HEADACHE. MED CLIN (BARC). 2019. 10.1016/J.MEDCLI.2019.03.023 SUMMARY: CLUSTER HEADACHE (CH) IS THE MOST SEVERE HEADACHE IN HUMANS AND IT BECOMES CHRONIC IN 10%-20% OF PATIENTS; IT CAN EVEN BECOME REFRACTORY TO ALL EFFECTIVE DRUGS IN 10% OF THOSE PATIENTS. IN THIS SITUATION, SURGICAL PROCEDURES ARE INDICATED: RADIOFREQUENCY OF THE SPHENOPALATINE GANGLION IPSILATERAL TO PAIN (RF-SPG), BILATERAL STIMULATION OF THE OCCIPITAL NERVES (GON-S) AND DEEP BRAIN STIMULATION (DBS) OF THE IPSILATERAL POSTERIOR INFERIOR HYPOTHALAMUS. SPECIFICALLY, THE EFFICACY AND SAFETY OF EACH OF THEM HAS BEEN ANALYZED, BUT THE EVOLUTION OF A SERIES OF PATIENTS FOLLOWING THIS SURGICAL ROUTE BY ORDER OF AGGRESSIVENESS HAS NOT BEEN DESCRIBED. PATIENTS WITH CHRONIC AND REFRACTORY CH ACCORDING TO THE CRITERIA OF THE EUROPEAN HEADACHE FEDERATION. THEY UNDERWENT, IN SEQUENCE, RF-SPG, GON-S IF THE PREVIOUS WAS INEFFECTIVE, AND DBS IF THE PREVIOUS WAS INEFFECTIVE. THE AUTHORS PROSPECTIVELY ENROLLED 44 PATIENTS BETWEEN NOVEMBER 2003 AND JUNE 2018 WITH AN AVERAGE AGE OF 38.3 YEARS, 70% OF THEM MALE. MEAN FOLLOW-UP WAS 87.4 MONTHS. 19 PATIENTS (33.3%) RESPONDED TO 74 RF-SPG PROCEDURES. OF THE REMAINING 25, A GON-S DEVICE WAS IMPLANTED IN 22 OF THEM, WITH AN EFFICACY OF 50%. LASTLY, 9 PATIENTS UNDERWENT DBS OF THE IPSILATERAL POSTERIOR INFERIOR HYPOTHALAMUS WITH AN EFFICACY OF 88.8%. NO SERIOUS COMPLICATIONS WERE OBSERVED IN ANY OF THE 3 PROCEDURES. THE SEQUENTIAL APPLICATION OF THE 3 SURGICAL PROCEDURES MANAGED TO REVERSE THE SEVERE CONDITION OF CHRONIC AND REFRACTORY CH DOWN TO EPISODIC CH IN 93% OF PATIENTS WITH ACCEPTABLE SURGICAL MORBIDITY. REPORTED EVENTS: 4 PATIENTS PRESENTED INFECTIONS OF THE SYSTEM AND REQUIRED A REPLACEMENT. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337142 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention