SOLETRA
Report
- Report Number
- 3007566237-2013-01314
- Event Type
- Injury
- Date Received
- April 16, 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
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
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 3387, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3387, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).
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 TO410 YEARS. MORE DATA ARE NEEDED TO EXPLAIN VARIATIONS IN INDIVIDUAL RESPONSES AND TO GUIDE INDIVIDUAL PROGRAMMING PARAMETERS. REPORTED EVENT: A (B)(6) MALE (PATIENT 3) REQUIRED A SECOND SURGERY AFTER 9 MONTHS TO HAVE ONE LEAD REMOVED DUE TO INFECTION THAT COULD NOT BE ADEQUATELY TREATED WITH INTRAVENOUS ANTIBIOTICS ALONE. STIMULATION OF THE GPI CONTRALATERAL TO THE OVERACTIVE STERNOCLEIDOMASTOID MUSCLE PROVIDED 3 YEARS OF GOOD CLINICAL BENEFIT BEFORE REPLACEMENT IN PATIENT 3. 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 |
|---|---|---|---|---|---|---|---|
| 163621 | SOLETRA | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC NEUROMODULATION | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00033 YR | Required Intervention |