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 2020-02-18 for LEAD MODEL 303 303-20 manufactured by Livanova Usa, Inc..
[180724446]
It was reported that the patient is referred for replacement due to the vns causing severe shaking and the patient cannot tolerate it. The patient previously complained of painful stimulation in the neck and chest which appears to now be related to the reason for the patient's referral. She noted discomfort up the middle of the chest in which she uses the magnet to turn off the device. The patient reported she is bothered by her vns and feels that it is misfiring and going up her chest rather than on the side of her neck. She cannot tolerate the device being set at 1. 0 ma or higher no known surgery has occurred to date. No additional information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00283 |
| MDR Report Key | 9723056 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-23 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2014-05-13 |
| Date Added to Maude | 2020-02-18 |
| 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 | LEAD MODEL 303 |
| Generic Name | LEAD |
| Product Code | MUZ |
| Date Received | 2020-02-18 |
| Model Number | 303-20 |
| Lot Number | 3943 |
| Device Expiration Date | 2018-05-08 |
| 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. Other | 2020-02-18 |