MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-02-10 for PULSE GEN MODEL 101 manufactured by Cyberonics Inc.
[16731251]
Reporter indicated via clinic notes received to the manufacturer that a vns pt had experienced a stroke on (b)(6) 2009. The vns was turned off from (b)(6) 2009 to (b)(6) 2009. Follow up with the reporter revealed the etiology of the stroke was unk, but that the pt was a 3 pack-a-day smoker. The relationship of the vns to the stroke event was unk. No interventions were performed for the stroke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2011-00237 |
| MDR Report Key | 1987523 |
| Report Source | 05,07 |
| Date Received | 2011-02-10 |
| Date of Report | 2011-01-12 |
| Date of Event | 2009-12-11 |
| Date Mfgr Received | 2011-01-12 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2011-02-16 |
| 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 | PULSE GEN MODEL 101 |
| Product Code | LYZ |
| Date Received | 2011-02-10 |
| Model Number | 101 |
| Lot Number | 8102 |
| Device Expiration Date | 2004-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-02-10 |