BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3193563 · Received June 27, 2013

    Report

    Report Number
    3007566237-2013-02137
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN. PRODUCT TYPE: EXTENSION: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 7427, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 7427, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_ENS_STIMULATOR, LOT# UNKNOWN. PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR: PRODUCT ID NEU_ENS_STIMULATOR, LOT# UNKNOWN. PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR: PRODUCT ID 7427, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 7427, LOT# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    MUELLER, O., HAGEL, V., WREDE, K., ET AL. STIMULATION OF THE GREATER OCCIPITAL NERVE: ANATOMICAL CONSIDERATIONS AND CLINICAL IMPLICATIONS. PAIN PHYSICIAN. 2013;16(3):E181-189. ISSN: 2150-1149 SUMMARY: STIMULATION OF THE GREATER OCCIPITAL NERVE HAS BEEN EMPLOYED FOR VARIOUS INTRACTABLE HEADACHE CONDITIONS FOR MORE THAN A DECADE. STILL, PROSPECTIVE STUDIES THAT CORRELATE STIMULATION OF THE GREATER OCCIPITAL NERVE WITH OUTCOME OF PATIENTS WITH RESPECT TO ALLEVIATION OF HEADACHE ARE SPARSELY FOUND IN LITERATURE. OBJECTIVE: TO IDENTIFY ANATOMICAL LANDMARKS FOR A REPRODUCIBLE STIMULATION OF THE GREATER OCCIPITAL NERVE. FOR THE CLINICAL IMPLICATION, THE INDIVIDUAL RESPONSE TO THERAPY OF PATIENTS WITH REFRACTORY CHRONIC CLUSTER HEADACHE UNDERGOING OCCIPITAL NERVE STIMULATION WAS CORRELATED WITH THE POSTOPERATIVE LOCALIZATION OF THE ELECTRODES AND WITH THE DISTRIBUTION OF THE STIMULATION FIELD. TEN FORMALDEHYDE FIXED HUMAN CADAVERS WERE DISSECTED TO IDENTIFY THE PASSAGE OF THE GREATER OCCIPITAL NERVE THROUGH THE TRAPEZIUS MUSCLE. THE DISTANCE TO THE EXTERNAL OCCIPITAL PROTUBERANCE WAS TRIANGULATED MEASURING THE DISTANCE OF THE NERVE FROM THE NUCHAL MIDLINE AND THE PROTUBERANCE. BETWEEN DECEMBER 2008 AND DECEMBER 2011, 21 CONSECUTIVE PATIENTS SUFFERING FROM CHRONIC CLUSTER HEADACHE UNDERWENT SURGERY IN TERMS OF BILATERAL OCCIPITAL NERVE STIMULATION, WITH ELECTRODES PLACED HORIZONTALLY AT THE LEVEL OF C1. THE POSTOPERATIVE X-RAYS WERE COMPARED WITH THE ACQUIRED LANDMARKS FROM THE ANATOMICAL STUDY. THE DISTRIBUTION OF THE STIMULATION FIELD WAS CORRELATED TO THE INDIVIDUAL RESPONSE OF EACH PATIENT TO THE THERAPY AND PROSPECTIVELY ANALYZED WITH REGARD TO REDUCTION OF DAILY CLUSTER ATTACKS AND RELIEF OF PAIN INTENSITY AT 3 MONTHS AND AT LAST FOLLOW-UP. THE GREATER OCCIPITAL NERVE CROSSES THE TRAPEZIUS MUSCLE AT A MEAN DISTANCE OF 31MM BELOW THE OCCIPITAL EXTERNAL PROTUBERANCE AND 14MM LATERAL TO THE MIDLINE AS FOUND IN THE ANATOMICAL SUBJECTS. THE ELECTRODES WERE TARGETED AT THIS LEVEL IN ALL OF OUR PATIENTS AND STIMULATED THE GREATER OCCIPITAL NERVE IN ALL PATIENTS. EIGHTEEN OF THE PATIENTS (85.7%) REPORTED A SIGNIFICANT REDUCTION OF THE FREQUENCY OF THEIR CLUSTER ATTACKS AND/OR DECLINED INTENSITY OF PAIN DURING THE ATTACKS. YET, 3 OF 21 PATIENTS (14.3%) DID NOT BENEFIT FROM THE STIMULATION DESPITE AN ADEQUATE SPREAD OF THE STIMULATION OVER THE OCCIPUT. THE SPREAD OF THE STIMULATION-INDUCED PARAESTHESIAS OVER THE OCCIPUT WAS NOT CORRELATED TO A REDUCTION OF CLUSTER ATTACKS, TO THE INTENSITY OF ATTACKS, OR TO THE RESPONSE TO TREATMENT AT ALL. FROM OUR STUDY WE CONCLUDE THAT A REPRODUCIBLE STIMULATION OF THE GREATER OCCIPITAL NERVE CAN BE ACHIEVED BY PLACING THE ELECTRODES PARALLEL TO THE ATLAS, AT ABOUT 30MM DISTANCE TO THE EXTERNAL OCCIPITAL PROTUBERANCE. THE RESPONSE TO THE STIMULATION IS NOT CORRELATED TO THE FIELD WIDTH OF THE PARAESTHESIA. WE, THEREFORE, CONSIDER STIMULATION OF THE MAIN TRUNK OF THE GREATER OCCIPITAL NERVE TO BE MORE IMPORTANT THAN A LARGE FIELD OF STIMULATION ON THE OCCIPUT. STILL, AN INDIVIDUAL RESPONSE TO THE OCCIPITAL NERVE STIMULATION CANNOT BE PREDICTED EVEN BY OPTIMAL ELECTRODE PLACEMENT. REPORTED EVENTS: 3 PATIENTS HAD LOCAL INFECTIONS REQUIRING EXPLANTATION OF THE LEADS AND REPLANTATION AFTER ANTIBIOTICAL ERADICATION. ONE PATIENT HAD LOCAL INFECTION BUT IT WAS NOT POSSIBLE TO IMPLANT ELECTRODES WITHOUT RECURRENT SYSTEMIC SEPTICAEMIC-LIKE INFECTIONS DESPITE PROLONGED SUBSTITUTION OF ANTIBIOTICS AFTER THE OPERATION. TWO PATIENTS HAD EXTENSION LEADS BREAK WHICH HAD TO BE REPLACED. ONE PATIENT HAD AN IATROGENIC LEAD DISLOCATION DURING THE IMPLANTABLE NEUROSTIMULATOR IMPLANTATION. FORTUNATELY, THE ELECTRODE DISLOCATED ONLY 2 CENTIMETERS AND THE STIMULATION FIELD WAS NOT ALTERED BY THIS MANEUVER. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICES INVOLVED IN THE COMPLICATIONS LISTED WERE NOT EXCLUSIVELY MEDTRONIC DEVICES. THE REPORTER STATED THAT NO MALFUNCTIONS HAD BEEN OBSERVED WITH ANY OF THE MEDTRONIC DEVICES. THE REPORTER STATED THAT DISLOCATION AND INFECTION OCCURRED IN TWO PATIENTS AND WERE REPORTED TWO YEARS PRIOR TO THIS REPORT. PLEASE NOTE THAT ONE INFECTION FROM EVENT 1 AND THE DISLOCATION WERE REPORTED IN MANUFACTURING REPORT # (B)(4). ANY ADDITIONAL INFORMATION RECEIVED REGARDING THESE TWO EVENTS WILL BE REPORTED IN MANUFACTURING REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293927 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention