MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-04-02 for LEAD MODEL 302 302-20 manufactured by Cyberonics, Inc..
[1295348]
Reporter indicated a vns pt had developed vocal cord paresis, and that the pt has had the problem since the vns was implanted on (b) (6) 2009. The vns was not turned on until early (b) (6) 2010, but the reporter indicated the vns would be disabled at the pt's office visit the following week as the paresis worsened slightly with vns stimulation. The reporter believes the vocal cord paresis was caused by the initial vns implant surgery, and not by the vns stimulation. Attempts to the reporter for further info are in progress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2010-00808 |
| MDR Report Key | 1651539 |
| Report Source | 05,07 |
| Date Received | 2010-04-02 |
| Date of Report | 2010-03-05 |
| Date of Event | 2010-03-05 |
| Date Mfgr Received | 2010-03-05 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2010-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NYDIA GRIMES |
| Manufacturer Street | 100 CYBERONICS BLVD., STE. 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal | 77058 |
| Manufacturer Phone | 2812287200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD MODEL 302 |
| Product Code | LYZ |
| Date Received | 2010-04-02 |
| Model Number | 302-20 |
| Lot Number | 201164 |
| Device Expiration Date | 2013-07-31 |
| 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 | CYBERONICS, INC. |
| Manufacturer Address | HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-02 |