BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2914486 · Received January 14, 2013

    Report

    Report Number
    3007566237-2013-00176
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT ID: 3487A, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: KISS, Z. H., BECKER, W. J. OCCIPITAL STIMULATION FOR CHRONIC MIGRAINE: PATIENT SELECTION AND COMPLICATIONS. THE CANADIAN JOURNAL OF NEUROLOGICAL SCIENCES. 2012. 39(6): 807-12. SUMMARY: CHRONIC MIGRAINE IS A SIGNIFICANT CAUSE OF DISABILITY WORLD-WIDE AND OCCIPITAL REGION STIMULATION (OS) HAS BEEN PROPOSED TO TREAT IT. WHILE PARTICIPATING IN AN INDUSTRY-SPONSORED PILOT TRIAL OF OS, WE AIMED TO COLLECT DATA REGARDING OUR SURGICAL COMPLICATIONS AND LONG TERM USAGE OF OS IN OUR CHRONIC MIGRAINE PATIENTS. TEN PATIENTS (8 FEMALE, MEDIAN AGE 46.5 YEARS) WERE ENROLLED BASED ON CRITERIA ESTABLISHED BY THE SPONSORING COMPANY, SCREENED IN THE HEADACHE CLINIC, AND FOLLOWED FOR A MEDIAN OF 33 MONTHS. WE DID NOT ACCESS DATA COLLECTED BY INDUSTRY FOR THIS REPORT AND INSTEAD COLLECTED OUR OWN DATA PROSPECTIVELY, INCLUDING PREDOMINANT LOCATION OF HEADACHE, LOCATION OF PARESTHESIA EVOKED BY OS, AND COMPLICATIONS. ADVERSE EVENTS INCLUDED THREE POSSIBLE EARLY INFECTIONS REQUIRING ANTIBIOTICS BUT NOT HARDWARE REMOVAL, ONE LATE IMPLANTABLE PULSE GENERATOR EROSION REQUIRING REMOVAL, ONE GENERATOR MALFUNCTION REQUIRING REVISION, AND LOSS OF PARESTHETIC COVERAGE REQUIRING FOUR REVISIONS IN FOUR PATIENTS. TWO PATIENTS EXPERIENCED NEW SYMPTOMS REQUIRING PSYCHIATRIC INTERVENTION. FIVE PATIENTS HAD NO BENEFIT ANDHAVE BEEN EXPLANTED. OF THOSE WHO REMAIN USING THEIR DEVICE, THE PROPORTION OF THEIR PRE-OPERATIVE PAIN LOCATED IN THE OCCIPITAL REGION WAS 0.62 ± 0.14, WHEREAS IN THOSE PATIENTS WHO HAVE BEEN EXPLANTED, THE PROPORTION WAS 0.31 ± 0.18 (T = 3.15, P=0.01). COMPLICATION RATES WITH OS ARE HIGHER THAN THOSE SEEN WITH OTHER ST IMULATION TECHNIQUES, DESPITE IDENTICAL HARDWARE AND SIMILAR SURGERY. THELOCATION OF MIGRAINE PAIN DID PREDICT OUTCOME, AND SUGGESTS THAT ONLY THOSE WITH PRIMARILY OCCIPITAL REGION HEADACHE ARE CANDIDATESFOR THIS THERAPY. REPORTED EVENT: A 36 YEAR OLD FEMALE EXPERIENCED GENERATOR MALFUNCTION THAT REQUIRED REVISION. THIS EVENT WAS ORIGINALLY REPORTED UNDER MASTER REGULATORY REPORT #3007566237-2012-03137. ADDITIONAL INFORMATION WAS RECEIVED WHICH PROVIDED PATIENT INFORMATION, INDICATING THE EVENT SHOULD BE REPORTED IN IT'S OWN REGULATORY REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED AS A SUPPLEMENTAL REPORT TO THIS REGULATORY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20755 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Required Intervention