MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-01-09 for ACTIVA 37612 manufactured by Medtronic Neuromodulation.
[174858793]
Concomitant medical products: product id: neu_unknown_lead, serial/lot #: unknown. Event country noted as (b)(6), however it is impossible to determine in which country the event occurred. The facilities listed in the article are (b)(6). Age. This value is the average age of the patients reported in the article as specific patients could not be identified. Sex. This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Date of event. Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature. Danielsson a, carecchio m, cif l, et al. Pallidal deep brain stimulation in dyt6 dystonia: clinical outcome and predictive factors for motor improvement. J clin med. 2019;8(12). 10. 3390/jcm8122163. If information is provided in the future, a supplemental report will be issued. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174858834]
Danielsson a, carecchio m, cif l, et al. Pallidal deep brain stimulation in dyt6 dystonia: clinical outcome and predictive factors for motor improvement. J clin med. 2019;8(12). 10. 3390/jcm8122163. Pallidal deep brain stimulation is an established treatment in dystonia. Available data on the effect in dyt-thap1 dystonia (also known as dyt6 dystonia) are scarce and long-term follow-up studies are lacking. In this retrospective, multicenter follow-up case series of medical records of such patients, the clinical outcome of pallidal deep brain stimulation in dyt-thap1 dystonia, was evaluated. It was determined in one patient that the electrodes and battery were disrupted and when this was discovered and corrected an abdominal wound infection developed which required prolonged antibiotic treatment. The patient subsequently improved. 3 years later the patient had a rapid loss of speech and difficulty swallowing which required a lead replacement. The patient's speech and swallowing returned to normal, however the patient failed to achieve >25% reduction in bfm movement score. In one patient an idiopathic edema along the lead track was discovered. This was later successfully treated with corticosteroids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2020-00053 |
| MDR Report Key | 9570149 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVA |
| Generic Name | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) |
| Product Code | MRU |
| Date Received | 2020-01-09 |
| Model Number | 37612 |
| Catalog Number | 37612 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-09 |