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 2020-01-06 for VITARIA GEN MODEL 7103 manufactured by Livanova Usa, Inc..
[173790107]
It was reported that the patient had postural dizziness with pre-syncope. It was indicated that this was considered a serious adverse event that was probably related to the presence of the implant and possibly related to stimulation. Additional details were received indicating that it was determined by the physician to probably be related to the vitaria implant due to the patient having intermittent nausea since the vitaria implant. The physician also determined that it was possibly related to the vitaria stimulation as the event occurred within an hour of the patient's settings being increased. The patient was provided with medication and was hospitalized. The event has now recovered/resolved. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00040 |
| MDR Report Key | 9553854 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-01-06 |
| 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 | MRS. RACHEL KOHN |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal | 77058 |
| Manufacturer Phone | 2812287200 |
| Manufacturer G1 | LIVANOVA USA, INC. |
| Manufacturer Street | 100 CYBERONICS BLVD SUITE 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 77058 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITARIA GEN MODEL 7103 |
| Generic Name | GENERATOR |
| Product Code | MUZ |
| Date Received | 2020-01-06 |
| Model Number | 7103 |
| 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 | LIVANOVA USA, INC. |
| Manufacturer Address | 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-06 |