MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-09 for VERCISE GEVIA DB-1200-S manufactured by Boston Scientific Neuromodulation.
[182711699]
A report was received that the deep brain simulation (dbs) patient has experienced approximately four seizures over the past year. After the episodes, the patient will not remember the name of his wife for a period of time. The nurse practitioner recommended that the patient start taking medication but the patient refused. During a reprogramming procedure, the patient experienced another seizure. The patient did not lose consciousness but was hot, had dilated pupils and was having difficulty speaking. The patient did not have a history of seizures prior to dbs. The physician and nurse practitioner concluded that the seizure was unrelated to the reprogramming. The patient will continue to be evaluated but does not want to take anti-seizure medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-01082 |
| MDR Report Key | 9808970 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2019-01-22 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TALAR TAHMASIAN |
| Manufacturer Street | 25155 RYE CANYON LOOP |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6619494863 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERCISE GEVIA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS |
| Product Code | NHL |
| Date Received | 2020-03-09 |
| Model Number | DB-1200-S |
| Catalog Number | DB-1200-S |
| Lot Number | 737289 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC NEUROMODULATION |
| Manufacturer Address | 25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-09 |