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 2019-11-26 for VERCISE GEVIA DB-1200-S manufactured by Boston Scientific Neuromodulation.
[168247784]
Additional suspect medical device components involved: product family: dbs-linear leads upn: (b)(4), model: sc-2202-45, serial: (b)(4), batch: 5137272. Product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7053779. The devices have not been returned for evaluation, therefore a failure analysis of the complaint devices could not be completed. A review of the devices history records will be conducted. If there is any further relevant information from that review, a supplemental med watch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[168247785]
A report was received that patient was not receiving adequate stimulation. The physician decided to schedule two separate appointments with the patient for reprogramming and troubleshooting. Post the reprogramming appointments patient still experienced inadequate stimulation and the physician decided to explant the ipg, right lead and extension, and replace them. Patient experienced a small brain bleed post operatively. He was subsequently discharged to an impatient rehabilitation hospital and is now home doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2019-06830 |
| MDR Report Key | 9379696 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-26 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-09-06 |
| Date Mfgr Received | 2019-11-01 |
| Device Manufacturer Date | 2019-05-08 |
| Date Added to Maude | 2019-11-26 |
| 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 | 2019-11-26 |
| Model Number | DB-1200-S |
| Catalog Number | DB-1200-S |
| Lot Number | 738310 |
| 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 | 2019-11-26 |