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 2020-03-23 for LEAD MODEL 304 304-20 manufactured by Cyberonics - Houston.
[184650882]
Device evaluated by mfr? Device evaluation is not necessary as the hemorrhage is not related to the functionality or delivery of therapy of the device.
Patient Sequence No: 1, Text Type: N, H10
[184650883]
It was reported that a bigger sheath had to be used during this patient's surgery because the smaller one was dropped and no longer sterile. The surgeon stated the patient was bleeding "a lot more" than anticipated, causing him to spend more time suctioning the blood out during the procedure. The surgeon thought the use of the larger tunneler was the cause of this. It was stated the patient had also had a tracheotomy in the past, and so even getting into the cartoid sheath had been challenging for the surgeon. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00494 |
| MDR Report Key | 9868366 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-04-11 |
| Date Added to Maude | 2020-03-23 |
| 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 | LYJ |
| Date Received | 2020-03-23 |
| Model Number | 304-20 |
| Lot Number | 204871 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2020-03-23 |