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 PULSE GEN MODEL UNKNOWN manufactured by Livanova Usa, Inc..
[177796217]
An article regarding the retrospective efficacy and safety using vns for treatment of resistant depression was received and reviewed. A total of 6 patients were observed in the study performed for one year. Adverse events during the one year were recorded indicating there were a total of 5 patients who had voice alteration, 2 that had worsening depression, 1 had coughing with stimulation, 2 had headaches with stimulation, 2 had painful stimulation, and 1 reported received no efficacy from vns. It was stated that during the year of observation, "there were no serious adverse events that might have resulted in patient hospitalization". No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00175 |
| MDR Report Key | 9664863 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-01-01 |
| 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 | 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 | PULSE GEN MODEL UNKNOWN |
| Generic Name | GENERATOR |
| Product Code | MUZ |
| Date Received | 2020-02-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Other | 2020-02-04 |