MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-24 for VITARIA GEN MODEL 7103 manufactured by Livanova Usa, Inc..
[180558403]
It was reported that an (b)(6) clinical trial patient experienced sudden cardiac death. The event was assessed as possibly related to vittaria implant as sudden cardiac death could be due to a fatal arrhythmia. It was also noted that the event was probably related to the patient's underlying condition as the patient is implanted with vns for heart failure. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00315 |
| MDR Report Key | 9745075 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-26 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-08-18 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 2020-02-24 |
| Model Number | 7103 |
| Lot Number | 204594 |
| 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. Death | 2020-02-24 |