BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 3559094 · Received January 7, 2014

    Report

    Report Number
    3007566237-2014-00063
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    May 17, 2013
    Report Date
    December 16, 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
    HEALTH PROFESSIONAL

    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. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE DEVICE WAS USED FOR OCCIPITAL NERVE STIMULATION FOR TREATMENT OF INTRACTABLE CHRONIC CLUSTER HEADACHE OR MIGRAINE. CONCOMITANT PRODUCTS: PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3888, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, LOT # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID 3888, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3888, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3888, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 7427, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MUELLER, O. OCCIPITAL NERVE STIMULATION FOR INTRACTABLE CHRONIC CLUSTER HEADACHE OR MIGRAINE: A CRITICAL ANALYSIS OF DIRECT TREATMENT COSTS AND COMPLICATIONS. CEPHALALGIA : AN INTERNATIONAL JOURNAL OF HEADACHE. 2013;33(16):1283-1291. SUMMARY: OCCIPITAL NERVE STIMULATION (ONS) HAS BEEN SHOWN TO BE EFFECTIVE FOR SELECTED PATIENTS WITH INTRACTABLE HEADACHE DISORDERS. WE PERFORMED A PROSPECTIVE CRITICAL EVALUATION OF COMPLICATIONS AND DIRECT TREATMENT COSTS. TWENTY-SEVEN PATIENTS WITH CHRONIC CLUSTER HEADACHE (CCH, N¼24) OR CHRONIC MIGRAINE (CM, N¼3) UNDERWENT A TRIAL PHASE WITH BILATERAL ONS AND SUBSEQUENT IMPLANTATION OF A PERMANENT GENERATOR (IPG), IF RESPONSIVE TO TREATMENT ACCORDING TO PREDEFINED CRITERIA. PROCEDURAL AND LONG-TERM COMPLICATIONS AS WELL AS DIRECT TREATMENT COSTS OF NEUROMODULATION THERAPY OF ONS WERE RECORDED OVER A MEAN FOLLOW-UP PERIOD OF 20 MONTHS (RANGE 5¿47 MONTHS). TWENTY-FIVE OF 27 PATIENTS (93%) RESPONDED TO TREATMENT. TWENTY-ONE COMPLICATIONS IN 14 PATIENTS WERE IDENTIFIED, NECESSITATING REOPERATION IN 13 CASES. OVERALL TREATMENT COSTS WERE (B)(6), INCLUDING HARDWARE-RELATED COSTS OF (B)(6), COSTS FOR PRIMARY HOSPITAL CARE OF (B)(4), AND COMPLICATIONS RELATED TO HOSPITALIZATION COSTS OF (B)(6). THIS RESULTS IN A PER CASE-BASED COST OF (B)(6) FOR HOSPITALIZATION AND (B)(64) FOR HARDWARE COSTS, TOTALING (B)(6). ONS FOR TREATMENT OF REFRACTORY CCH AND CM IS A COST-INTENSIVE TREATMENT OPTION WITH A SIGNIFICANT COMPLICATION RATE. NEVERTHELESS, PATIENTS WITH REFRACTORY PRIMARY HEADACHE DISORDERS MAY EXPERIENCE SUBSTANTIAL RELIEF OF PAIN ATTACKS, AND HEADACHE DAYS, RESPECTIVELY. REPORTED EVENTS: 2 PATIENTS EXPERIENCED INFECTIONS LEADING TO THE EXPLANTATION OF THE HARDWARE. IT WAS NOTED THAT THE PATIENTS EXPERIENCED RECURRENT INFECTIONS REQUIRING SEVERAL SURGICAL INTERVENTIONS. THE REPORTER STATED THAT THE REPETITIVE GENERALIZED INFECTIONS OCCURRED DESPITE EXTREMELY CAREFUL HANDLING, STRICT ASEPTIC PROCEEDINGS AND, AFTER THE FIRST RELAPSE, PERFORMING AN ALL-IN-ONE IMPLANTATION AFTERWARD. THE REPORTER STATED THAT BOTH PATIENTS SUFFERED FROM DEFILEMENT OF THE SKIN AND ACNE WITH HISTORY OF RECURRENT PUSTULES. IT WAS NOTED THAT AFTER SUFFERING INFECTIONS FOR THE SECOND TIME, IMPLANTATION WAS ABANDONED IN BOTH PATIENTS. ONE PATIENT EXPERIENCED AN INFECTION AT THE INS SITE, FAR FROM THE EXTERNALIZATION OF THE EXTENSIONS AND AFTER THE REMOVAL OF THE EXTENSION LEADS. THE PATIENT REPORTEDLY SUFFERED A LOCALIZED INFECTION AROUND THE CONNECTOR OF THE STIMULATION LEAD PRIOR TO THE INS INFECTION, DUE TO A FISTULA THAT WAS CAUSED BY THE LACED THREAD SECURING THE CONNECTOR. ONE PATIENT DEVELOPED AN INFECTION AT THE INS SITE, FAR FROM THE EXTERNALIZATION OF THE EXTENSIONS AND AFTER THE REMOVAL OF THE EXTENSION LEADS. TWO PATIENTS HAD THE GLUTEAL IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED DUE TO SCIATIC IRRITATIONS. ONE PATIENT COMPLAINED OF LOCAL PAIN AT THE CONNECTOR SITE AND HAD A REVISION. ONE STIMULATION ELECTRODE DEVELOPED A MALFUNCTION AFTER 46 MONTHS AND HAD TO BE REVISED. ONE PATIENT REQUIRED AN EXTENSION REPLACEMENT. THE REPORTER STATED THAT DURING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY, THE EXTENSION LEAD HAD PRESUMABLY BROKE AND THEREFORE HAD TO BE EXCHANGED IN ANOTHER OPERATION. ONE EXTENSION LEAD HAD TO BE EXCHANGED FOUR WEEKS AFTER IMPLANTATION. THE REPORTER STATED THAT TECHNICAL INVESTIGATION OF THE ELECTRODE SUGGESTED A DAMAGE OF THE ISOLATION, SUGGESTING AN IATROGENIC COMPLICATION. IT WAS NOTED THAT PERI- AND POSTOPERATIVE TESTING OF THE SYSTEM IN THE PATIENT SHOWED NORMAL RESISTANCES. THE EXTENSION LEAD REPORTEDLY HAD TO BE REPLACED AND THE SYSTEM REPORTEDLY WORKED SINCE. ONE LEAD WIRE BROKE AFTER FOUR MONTHS, BUT STIMULATION COULD BE PERFORMED FOR BOTH SIDES WITH THE CONTRALATERAL ELECTRODE. THE BROKEN LEAD THEREFORE DID NOT HAVE TO BE REPLACED. THIS PATIENT ALSO HAD AN IATROGENIC LEAD DISPLACEMENT OF AN ELECTRODE. THE REPORTER STATED THAT WHEN THE EXTENSION WIRES WERE EXCHANGED DURING INS IMPLANTATION, THE STIMULATION LEAD WAS PRESUMABLY PULLED FOR TOO LONG, DISPLACING IT FOR ABOUT 3CM COMPARED TO PREOPERATIVE X-RAYS. THE REPORTER STATED THAT THE LEAD WAS IN PLACE TO ESTABLISH A SUFFICIENT STIMULATION OVER THE OCCIPUT IN THE PATIENT, EVEN MORE COVERING THE CONTRALATERAL SITE WITH THE BROKEN LEAD. ONE PATIENT EXPERIENCED A LOSS OF STIMULATION EFFECT AFTER SIX MONTHS, DESPITE EVERY CONCEIVABLE REPROGRAMMING OF THE STIMULATION WITH REGARDS TO PULSE WIDTH, AMPLITUDE, FREQUENCY AND CONTINUOUS AND DISCONTINUOUS STIMULATION. THE REPORTER STATED THAT THE PATIENT FINALLY RECEIVED INTRAVENOUS DIHYDROERGOTAMINE AS AN OFF-LABEL MEDICATION, WHICH CONTROLLED THE CHRONIC CLUSTER HEADACHES (CCH) FOR A FOLLOW-UP PERIOD OF EIGHT MONTHS AT THE TIME OF THIS REPORT. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE RE-OPERATION. 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
    8914 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention