MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for LEAD MODEL 302 302-20 manufactured by Cyberonics - Houston.
[188030250]
It was reported that a patient underwent a full revision due to an issue with the lead. High impedance could not be seen on the old generator due to the generator being completely depleted and unable to be interrogated. The high impedance was seen on the new generator and this generator was also checked with the test resistor pin to ensure lead issue. Generator diagnostics were within normal limits and therefore the lead was replaced. Information was received that there were lead problems seen during surgery. In response to requesting the physician's assessment of the high impedance, it was stated that the old vns was dead generator test could not be done. The explanted devices were stated to be discarded and therefore not received into analysis to date. Device history records were reviewed and the device passed all functional specifications and quality tests and were sterilized prior to distribution. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00524 |
| MDR Report Key | 9900747 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-01-28 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2020-03-30 |
| 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 302 |
| Generic Name | LEAD |
| Product Code | LYJ |
| Date Received | 2020-03-30 |
| Model Number | 302-20 |
| Lot Number | 334223 |
| Device Expiration Date | 2010-02-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-30 |