MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for LEAD MODEL 303 303-20 manufactured by Cyberonics - Houston.
[188029732]
Product analysis was completed on a lead that was explanted due to an infection (captured in mfr. Report # 1644487-2020-00352). The electrode portion of the lead was not received and so an analysis on that portion of the lead could not be completed. An abraded open was noted in the silicone tubing resulting in portion of the negative coil being exposed. The tubing had dried remnants of apparent body fluids inside with no obvious point of entrance noted other than the abraded opening and the cut ends of the returned lead portions. No other anomalies were identified in the returned lead portions. Product analysis was completed on the returned generator. A comprehensive electrical evaluation showed that the device performed according to functional specifications. Per the internal data of the generator, impedance was within normal limits during implant per the last 10 >25% changes in impedance. No further relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00505 |
| MDR Report Key | 9881961 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2020-03-26 |
| 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 | CYBERONICS - HOUSTON |
| 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 | LYJ |
| Date Received | 2020-03-26 |
| Model Number | 303-20 |
| Lot Number | 2595 |
| Device Expiration Date | 2014-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYBERONICS - HOUSTON |
| Manufacturer Address | 100 CYBERONICS BLVD HOUSTON TX 77058 US 77058 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |