BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 2893703 · Received January 2, 2013

    Report

    Report Number
    3007566237-2013-00012
    Event Type
    Death
    Date Received
    January 2, 2013
    Date of Event
    February 13, 2012
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MENDES MARTINS, V., COSTE, J., DEROST, P., ULLA, M., GABRILLARGUES, J., DURIF, F., CHAZAL, J., LEMAIRE, J. J. SURGICAL COMPLICATIONS OF DEEP BRAIN STIMULATION: CLINICAL EXPERIENCE OF 184 CASES. NEUROCHIRURGIE. 2012 AUG 2012;58(4):219-224. DOI: 10.1016/J.NEUCHI.2012.02.004. SUMMARY: DEEP BRAIN STIMULATION IS A RECOGNIZED TREATMENT FOR MOVEMENT DISORDERS AND CERTAIN PSYCHIATRIC DISEASES. HOWEVER, IT IS STILL A TIME-CONSUMING, DELICATE SURGICAL PROCEDURE WHICH CAN INVOLVE COMPLICATIONS. WE HAVE ANALYZED THE ADVERSE EVENTS THAT WERE NOT INDUCED BY STIMULUS AND WHICH OCCURRED OVER THE COURSE OF 14 YEARS AND THE UNIVERSITY HOSPITAL CENTER (UHC) OF CERMONT-FERRAND, WHERE WE CARRY OUT DIRECT STEREOTACTIC TARGETING BASED ON NUCLEAR MAGNETIC RESONANCE IMAGING (MRI). ONE HUNDRED AND SEVENTY-FIVE PATIENTS WERE TREATED BETWEEN 1994 AND 2008 FOR: IDIOPATHIC PARKINSON'S DISEASE, ESSENTIAL TREMOR, DYSTONIA AND OBSESSIONAL COMPULSIVE DISORDER. THE PRIMARY ANATOMICAL TARGETS WERE: THE SUB-THALAMIC REGION, THE PALLIDUS INTERNUS OR THE THALAMUS. THE ELECTRODES WERE POSITIONED AFTER NEURON RECORDINGS AND ACUTE STIMULATION TESTS. ALL ADVERSE EVENTS WERE COLLECTED AND ANALYZED RETROSPECTIVELY; LIFE-THREATENING OR UNPLANNED SURGERY WAS CONSIDERED A SEVERE ADVERSE EVENT. THE NUMBER OF ADVERSE EVENTS RESULTING FROM INTERVENTION WAS TEN DURING MRI ACQUISITION (5.4%), 24 DURING THE POSITIONING OF THE ELECTRODES (13%), FIVE SERIOUS CASES INCLUDING 1 DEATH (0.5%), AND 17 DURING THE IMPLANTATION OF THE NEUROSTIMULATOR (9.2%; FOUR SERIOUS 2.2%). FIVE PATIENTS (SIX CASES OF SURGERY, 3.4%) UNDERWENT REPOSITIONING OF THE ELECTRODES. THE EFFECTIVENESS OF DEEP BRAIN STIMULATION IS NO LONGER A SUBJECT FOR DEBATE, BUT THE SIGNIFICANT NUMBER OF ADVERSE EVENTS SHOULD PROMPT US TO IMPROVE PROCEDURES. REPORTED EVENTS: 1 PATIENT DIED 12 HOUR AFTER IMPLANTATION OF THE LEADS. THERE WAS NO IDENTIFIED CAUSE OF DEATH. POST-MORTEM TOMODENSITOMETRY WAS NORMAL AND AN AUTOPSY WAS REFUSED. NO ADDITIONAL INFORMATION IS AVAILABLE. 8 INFECTIONS WERE REPORTED. TWO OCCURRED AT THE LEAD SITE AND REQUIRED LEAD EXPLANT. THREE OCCURRED AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE AND REQUIRED SURGICAL INTERVENTION. ONE INFECTION WAS DUE TO A FAILED SCAR UNION AND WAS TREATED MEDICALLY. TWO URINARY INFECTIONS WERE TREATED MEDICALLY. FIVE HEMATOMAS WERE REPORTED. ONE HEMATOMA WAS INTRACEREBRAL AND REQUIRED EMERGENCY SURGICAL EVACUATION. ONE HEMATOMA AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE REQUIRED SURGICAL INTERVENTION. THREE OTHER HEMATOMAS AT THE POCKET SITE WERE TREATED MEDICALLY. TWO FRACTURES OF THE EXTENSION WERE REPORTED. REVISION SURGERY WAS REQUIRED IN BOTH CASES. ONE PATIENT EXPERIENCED A TONIC-CLONIC EPILEPTIC SEIZURE. THREE PATIENTS EXPERIENCED POOR POSITIONING OF THE ELECTRODE DUE TO LEAD MIGRATION. TWO PROCEDURES WERE STARTED BUT NOT COMPLETED DUE TO PATIENT ANXIETY WHICH PREVENTED COOPERATION BY THE PATIENT DURING THE ELECTROPHYSIOLOGICAL EXPLORATION PHASE. FIVE PATIENTS EXPERIENCED A LACK OF THERAPEUTIC EFFECT. SURGICAL REVISION WAS PERFORMED 1 PATIENT UNDERWENT SURGICAL REVISION FOR SIGNIFICANT DYSARTHRIA. 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
    347 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death