MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-01-23 for VERCISE CARTESIA DB-2202-45 manufactured by Boston Scientific Neuromodulation.
[176077789]
Date of birth - (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[176077790]
It was reported that the vercise cartesia directional lead was implanted. The patient later experienced a life threatening seizure. The patient was admitted to the hospital on the same day the reported event occurred and was treated with lacosamide. The patient recovered and was later discharged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00161 |
| MDR Report Key | 9622659 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2020-01-23 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-25 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2018-03-12 |
| Date Added to Maude | 2020-01-23 |
| 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 | ROAD 698, LOT NO. 12 |
| Manufacturer City | DORADO PR 00646-260 |
| Manufacturer Country | RQ |
| Manufacturer Postal Code | 00646-2602 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERCISE CARTESIA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS |
| Product Code | NHL |
| Date Received | 2020-01-23 |
| Model Number | DB-2202-45 |
| Catalog Number | DB-2202-45 |
| Lot Number | 5027120 |
| Device Expiration Date | 2020-03-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-01-23 |