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 2020-01-30 for LEAD MODEL 304 304-20 manufactured by Cyberonics - Houston.
[183965949]
During a generator replacement due to battery depletion, the patient presented with high impedance once the new generator was connected to the lead. Pre-op diagnostics could not be performed to determine the impedance, since the patient's generator had reached end of service. The leads were adjusted, the surgeon checked for any visual fractures, took steps to relieve back pressure, made sure the nerve was irrigated and multiple system diagnostic tests were performed but high impedance was still observed, this is captured in mfr. Report #1644487-2020-00142. Generator diagnostics were performed with a test resistor and the impedance was normal, so a generator issue was ruled out. The surgeon then replaced the lead and checked for correct placement on the nerve and high impedance was still observed, this is captured in mfr. Report # 1644487-2020-00141. The lead was then replaced again (captured in this mfr. Report) and high impedance was still observed and the patient was closed. A review of device history records was performed and revealed that the lead passed quality control inspection prior to distribution for the lead that was opened but not used. The surgeon then mentioned that she is unsure of the cause of the high impedance, but a fairly thick layer of fibrous tissue was observed on the patient's nerve. No further surgical intervention has occurred to date. No other relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00140 |
| MDR Report Key | 9648523 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-01-30 |
| 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 304 |
| Generic Name | LEAD |
| Product Code | MUZ |
| Date Received | 2020-01-30 |
| Model Number | 304-20 |
| Lot Number | 6497 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-01-30 |