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 2020-01-28 for ACTIVA 37612 manufactured by Medtronic Neuromodulation.
[176759340]
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. Lasky l, bliss l, sidiropoulos c. Successful pallidal deep brain stimulation treatment in a case of generalized dystonia due to a novel ano3 mutation. Case rep neurol med. 2019;2019:3154653. 10. 1155/2019/3154653. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[176759341]
Lasky l, bliss l, sidiropoulos c. Successful pallidal deep brain stimulation treatment in a case of generalized dystonia due to a novel ano3 mutation. Case rep neurol med. 2019;2019:3154653. 10. 1155/2019/3154653 abstract: this study presents a long term, longitudinal follow up of a patient with generalized dystonia, who was treated with bilateral pallidal deep brain stimulation and was found to harbor a mutation in the anoctamin-3 gene. Reported events: it was stated that since dbs implant, over a period of 5 years, the patient had 5 episodes of dystonic storms which required hospitalization with frequent and high dosing of intravenous benzodiazapines, as well as baclofen and benztropine. The patient also over time developed a mild but tolerable bilateral upper extremity bradykinesia. Following the hospitalizations the patient was discharged on additional benzodiazepines which were weaned down as an outpatient. The patient has not had any issues of dystonic storms since (b)(6) 2018. They have no limitations at all in their ambulation and hand dexterity, and they have minimal to no dystonic symptoms. It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event. See attached literature article.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007566237-2020-00150 |
| MDR Report Key | 9638957 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-11-29 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-01-28 |
| 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 | 2020-01-28 |
| 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. Hospitalization | 2020-01-28 |