MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-09-27 for BIPOL LEAD MODEL 300 300-20 * manufactured by Cyberonics, Inc..
[19951423]
Reporter indicated that the vns patient underwent reimplantation of the vns system due to high lead impedance. During the investigation of the high impedance, it was confirmed that the normal mode and system diagnostics results prior to the reimplant surgery, resulted in lead impedance high indicating a possible lead break. Reported review of the x-rays by the site did not show any lead discontinuities and the implanting physician reported that he did not visualize any lead discontinuities during the reimplant procedure. Approximately 38cm of the lead assembly was returned for evaluation in one piece with the lead connectors. The electrode portion of the lead was not returned. The product analysis completed on the returned piece did not show any lead discontinuities.
Patient Sequence No: 1, Text Type: D, B5
[20039503]
The entire lead assembly was not returned for product analysis. The portion tested did not indicate device failure, however, cyberonics suspects the malfunction occurred in the portion of the lead not returned. Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1644487-2006-00360 |
| MDR Report Key | 862334 |
| Report Source | 05,07 |
| Date Received | 2006-09-27 |
| Date of Report | 2006-08-28 |
| Date Mfgr Received | 2006-07-20 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2007-06-11 |
| 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 | 0 |
| Manufacturer Contact | DONNIE WELTY, RN, BSN |
| Manufacturer Street | 100 CYBERONICS BLVD STE. 600 |
| Manufacturer City | HOUSTON TX 77058 |
| Manufacturer Country | US |
| Manufacturer Postal | 77058 |
| Manufacturer Phone | 2812287200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPOL LEAD MODEL 300 |
| Generic Name | LYZ |
| Product Code | LYZ |
| Date Received | 2006-09-27 |
| Returned To Mfg | 2006-07-20 |
| Model Number | 300-20 |
| Catalog Number | * |
| Lot Number | 32572C |
| ID Number | * |
| Device Expiration Date | 2001-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 845321 |
| Manufacturer | CYBERONICS, INC. |
| Manufacturer Address | 100 CYBERONICS BLVD. * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-27 |