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 2020-03-26 for VERCISE GEVIA DB-1200-S manufactured by Boston Scientific Neuromodulation.
[185915218]
It was reported that the during a reprogramming visit the physician made several changes to the patients medication and referred him to physical therapy. A cat scan was taken that indicated no changes to the location of the leads. It was later reported that when the patient was trying to connect their ipg the patient felt multiple adverse effect such as severe shock, tingling and muscle tightening in his face, right side of the body, arm and leg which only lasted for a few minutes. During a follow up visit with the physician the patient experienced the same adverse effects while connecting to the clinician programmer but did not last as long. The patient was reprogrammed and the patients adverse symptoms did not occur again. Two database analysis were performed and revealed no anomalies, the ipg appears to be working as expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-01477 |
| MDR Report Key | 9886950 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-09-11 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | DB-1200-S |
| Catalog Number | DB-1200-S |
| Lot Number | 739832 |
| 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 | 2020-03-26 |