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 2020-02-04 for VITARIA GEN MODEL 7103 manufactured by Cyberonics - Houston.
[177760355]
It was reported that a patient was admitted into the hospital due to complaints of shortness of breath, which they were experiencing for one week and has been aggravated for two days, generalized weakness, and multiple episodes of vomiting. It was stated the patient has no history of similar events in the recent past. Patient is diagnosed to have complete heart block and the physician advised stopping vns and permanent pacemaker implantation (ppi). Vns was disabled. Information was later received that the subject was hospitalized with the symptoms of shortness of breath, vomiting, and fatigue however after evaluation of the case investigator determined this event to be? Complete heart block?. Complete heart block was determined to be unrelated to vns. Atrial fibrillation was determined to be possibly related to vns stimulation. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00178 |
| MDR Report Key | 9668220 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-04 |
| 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 | CYBERONICS - HOUSTON |
| 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 | 2020-02-04 |
| Model Number | 7103 |
| Lot Number | 202820 |
| Device Expiration Date | 2016-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERONICS - HOUSTON |
| Manufacturer Address | 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-02-04 |