BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3830505 · Received May 23, 2014

    Report

    Report Number
    3007566237-2014-01427
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    August 27, 2013
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. 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. 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. THE DEVICE WAS USED FOR PERIPHERAL NERVE STIMULATION TO TREAT CHRONIC HEADACHE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; 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; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    VERRILLS, P., ROSE, R., MITCHELL, B., VIVIAN, D., BARNARD, A. PERIPHERAL NERVE FIELD STIMULATION FOR CHRONIC HEADACHE: 60 CASES AND LONG-TERM FOLLOW-UP. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2014;17(1):54-59. DOI: 10.1111/NER.12130. SUMMARY: THE OBJECTIVE OF THIS STUDY IS TO EVALUATE THE EFFICACY OF PERIPHERAL NERVE FIELD STIMULATION (PNFS) FOR THE TREATMENT OF CHRONIC HEADACHE CONDITIONS. FOR MORE THAN A FOUR-YEAR PERIOD, 83 PATIENTS UNDERWENT A TRIAL OF A PNFS SYSTEM TARGETING THE NERVE REGIONS INCLUDING OCCIPITAL AND SUPRAORBITAL AND INFRAORBITAL NERVES, WHICH BEST CORRESPONDED WITH THEIR AREA OF HEAD PAIN. SIXTY PATIENTS REPORTED A SUCCESSFUL TRIAL AND UNDERWENT A SUBSEQUENT IMPLANT OF THE PNFS SYSTEM. QUESTIONNAIRES, ALONG WITH PATIENTS¿ CHARTS, WERE USED TO ASSESS OUTCOMES AS FOLLOWS: PAIN (11-POINT NUMERICAL PAIN RATING SCALE), ANALGESIC USE, DEPRESSION (ZUNG DEPRESSION SCALE), DISABILITY (NECK DISABILITY INDEX), PATIENT SATISFACTION, AND SURGICAL COMPLICATIONS. PATIENTS WERE FOLLOWED UP FOR AN AVERAGE OF 12.9 ± 9.4 MONTHS (RANGE 3¿42 MONTHS). AN AVERAGE PAIN REDUCTION OF 4.8 ± 2.3 PAIN SCALE POINTS WAS OBSERVED (PREIMPLANT 7.4 ± 1.6; FOLLOW-UP 2.6 ± 2.1 [P = 0.001]). OF THE 60 PATIENTS IMPLANTED, 41 REPORTED >50% PAIN RELIEF. MEDICATION USE WAS REDUCED IN 83% OF PATIENTS WHO WERE PREVIOUSLY TAKING ANALGESICS OR PROPHYLACTIC MEDICATIONS. SIMILARLY, REDUCTIONS IN DEGREE OF DISABILITY AND DEPRESSION ALSO WERE OBSERVED. OF THE 60 CASES, TEN SURGICAL REVISIONS WERE REQUIRED; HOWEVER, NO LONG-TERM COMPLICATIONS WERE REPORTED. PNFS FOR CHRONIC HEADACHE IS AN EVOLVING THERAPY. THIS STUDY DEMONSTRATES THAT THIS REVERSIBLE AND EFFECTIVE TREATMENT CAN BE A PROMISING PAIN RELIEF STRATEGY FOR THIS OFTEN INTRACTABLE CONDITION. REPORTED EVENTS: 6 PATIENTS IMPLANTED WITH PERIPHERAL NERVE FIELD STIMULATION (PNFS) FOR CHRONIC HEADACHE HAD HARDWARE EROSION WHICH RESULTED IN A SURGICAL REVISION WITH A POSITIVE OUTCOME. ONE PATIENT IMPLANTED WITH PNFS FOR CHRONIC HEADACHE HAD HARDWARE EROSION WHICH RESULTED IN A SYSTEM EXPLANT. ONE PATIENT IMPLANTED WITH PNFS FOR CHRONIC HEADACHE HAD HARDWARE FAILURE WHICH RESULTED IN SURGICAL REVISION WITH A POSITIVE OUTCOME. ONE PATIENT IMPLANTED WITH PNFS FOR CHRONIC HEADACHE HAD LEAD MIGRATION WHICH RESULTED IN A SURGICAL REVISION WITH A POSITIVE OUTCOME. ONE PATIENT IMPLANTED WITH PNFS FOR CHRONIC HEADACHE DID NOT HAVE ENOUGH ¿REDUNDANCY¿ IN THE IMPLANTED LEAD RESULTING IN THE LEADS PULLING AND FEELING TIGHT DURING HYPEREXTENSION. IT WAS NOTED THAT THIS RESULTED IN A SURGICAL REVISION WITH A POSITIVE OUTCOME. FOUR PATIENTS IMPLANTED WITH PNFS FOR CHRONIC HEADACHE EXPERIENCED INFECTION. THE REPORTER STATED THAT ONE OF THESE INFECTIONS OCCURRED ONE YEAR POST-IMPLANT FOLLOWING MINOR TRAUMA OVER THE OCCIPITAL LEAD AREA. IT WAS NOTED THAT OF THE FOUR INFECTIONS, THREE RESULTED IN SYSTEM EXPLANT. IT WAS NOTED THAT ONE INFECTION ONLY REQUIRED SURGICAL REVISION. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    308087 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 00053 YR Required Intervention