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 2020-02-25 for VERCISE GEVIA DB-1200-S manufactured by Boston Scientific Neuromodulation.
[180784619]
Additional suspect medical device components involved in the event: brand name: vercise cartesia, upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5167840 and 5174087.
Patient Sequence No: 1, Text Type: N, H10
[180784620]
A report was received that the patient experienced a stroke 2 to 3 weeks post implant of the stimulation devices. The patient underwent an mri, magnetic resonance imaging, and per the physician no signs of stroke were observed. The physician stated that the incident is not device related, and that nothing happened during the procedure that may have contributed to the event. The patient has been referred to undergo physical therapy. The patient underwent programming of the device and is doing well post the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00775 |
| MDR Report Key | 9751352 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| Model Number | DB-1200-S |
| Catalog Number | DB-1200-S |
| Lot Number | 741103 |
| 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 | 2020-02-25 |