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 PULSE GEN MODEL 102 manufactured by Cyberonics, Inc..
[1298045]
Reporter indicated a vns pt had the vns lead and generator explanted due to "malfunction". The malfunction was not specified. The explanted lead and generator have been returned. Analysis of the lead portion returned did not identify any anomalies. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. The electrode array was not returned. Analysis of the generator is still pending. Attempts for further info are in progress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2010-00807 |
| MDR Report Key | 1655336 |
| Report Source | 05,07 |
| Date Received | 2010-04-02 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2010-03-04 |
| Device Manufacturer Date | 2002-12-01 |
| Date Added to Maude | 2010-08-03 |
| 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 102 |
| Product Code | LYZ |
| Date Received | 2010-04-02 |
| Returned To Mfg | 2010-03-08 |
| Model Number | 102 |
| Lot Number | 7416 |
| Device Expiration Date | 2004-11-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-04-02 |