BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3063039 · Received April 17, 2013

    Report

    Report Number
    3007566237-2013-01321
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    December 21, 2012
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    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. PRODUCT ID: 3387, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WALSH, R. A., SIDIROPOULOS, C., LOZANO, A. M., HODAIE, M., POON, Y-Y., FALLIS, M., MORO, E. BILATERAL PALLIDAL STIMULATION IN CERVICAL DYSTONIA: BLINDED EVIDENCE OF BENEFIT BEYOND 5 YEARS. BRAIN : A JOURNAL OF NEUROLOGY. 2013;136(PT 3):761-769. DOI: 10.1093/BRAIN/AWT009. SUMMARY: THE LOCAL INJECTION OF BOTULINUM TOXIN IS ACCEPTED AS THE FIRST-LINE TREATMENT OF PRIMARY CERVICAL DYSTONIA. THIS APPROACH PROVIDES ADEQUATE SYMPTOMATIC RELIEF FOR MOST PATIENTS, BUT UP TO ONE-THIRD WILL HAVE AN UNSATISFACTORY RESPONSE. DEEP BRAIN STIMULATION OF THE GLOBUS PALLIDUS INTERNUS HAS BEEN INCREASINGLY USED IN DYSTONIC SYNDROMES THAT ARE REFRACTORY TO BEST PHARMACOLOGICAL APPROACHES. ALTHOUGH CERVICAL DYSTONIA IS THE MOST COMMON IDIOPATHIC FOCAL DYSTONIA, EVIDENCE FOR LONG-TERM RESPONSIVENESS TO PALLIDAL STIMULATION IS LIMITED. THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO PROSPECTIVELY COLLECT OUTCOME DATA FROM BASELINE TO LAST CLINICAL FOLLOW-UP ON PATIENTS WITH IDIOPATHIC CERVICAL DYSTONIA TREATED WITH BILATERAL PALLIDAL STIMULATION. BLINDED VIDEO ASSESSMENT OF EXAMINATIONS PERFORMED PREOPERATIVELY AND AT LAST VIDEO ASSESSMENT WERE PERFORMED. TEN PATIENTS HAD COMPLETE PROSPECTIVE CLINICAL FOLLOW-UP. BASELINE TOTAL TORONTO WESTERN SPASMODIC TORTICOLLIS RATING SCALE SCORE (STANDARD DEVIATION) WAS 54.5 +/- 12.4 (RANGE, 35.0-70.3). COMPARISON OF THE BLINDED SEVERITY SUB-SCORE ON BASELINE VIDEO AND AT LAST VIDEO ASSESSMENT AT A MEAN OF 7.7 YEARS POSTOPERATIVELY DEMONSTRATED A MEAN IMPROVEMENT OF 47.6% (P = 0.002) AND STRONG INTER-OBSERVER CORRELATION BETWEEN BLINDED RATERS (SPEARMAN R = 0.78, 95% CONFIDENCE INTERVAL 0.49-0.92, P = 0.0001). ALL 10 PATIENTS HAD 5 YEARS OF OPEN PROSPECTIVE FOLLOW-UP, DOCUMENTING A 47 .4 +/- 26.4% (P50.01) MEAN IMPROVEMENT WITH RESPECT TO BASELINE. THIS WAS MAINTAINED AT A MEAN OF 7.8 YEARS AT LAST FOLLOW-UP AFTER SURGERY (RANGE, 4.9-10.7 YEARS) WITH A 54.4 +/- 27.4% MEAN IMPROVEMENT (P50.01). DEEP BRAIN STIMULATION OF THE GLOBUS PALLIDUS IS AN EFFECTIVE AND LONG-LASTING SECOND-LINE TREATMENT OF CERVICAL DYSTONIA, WITH BENEFIT IN SOME OF OUR PATIENTS EXTENDING TO >10 YEARS. MORE DATA ARE NEEDED TO EXPLAIN VARIATIONS IN INDIVIDUAL RESPONSES AND TO GUIDE INDIVIDUAL PROGRAMMING PARAMETERS. REPORTED EVENT: A 66 YEAR OLD FEMALE (PATIENT 8) HAD BOTH LEADS REPOSITIONED WITHIN THE GLOBUS PALLIDUS INTERNUS AFTER AN INITIAL 48% IMPROVEMENT AT 1 YEAR HAD DIMINISHED TO 19% AT 2 YEARS. MOST NOTABLE IN THE DETERIORATION WAS A LOSS OF PAIN RESPONSE SEEN AFTER 1 YEAR. IT WAS DETERMINED THAT THE LEAD PLACEMENT WAS SUBOPTIMAL AND A SECOND SURGERY WAS PERFORMED. BOTH LEADS WERE REPLACED IN A SITE IMMEDIATELY POSTERIOR TO THE ORIGINAL SITE OF STIMULATION, WHICH ON POSTOPERATIVE MRI APPEARED TO BE LOCALIZED BETTER TO THE POSTERIOR PORTION OF THE GPI. THERE WAS AN IMPROVEMENT OF 45% FOLLOWING THE SECOND SURGERY WITH THE PAIN SUB-SCORE DROPPING TO 0 AT THE FIRST ASSESSMENT AFTER THE SECOND SURGERY. 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
    164076 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention