MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-23 for PULSE GEN MODEL 1000 manufactured by Cyberonics - Houston.
[188029120]
It was reported that the patient has had seizures at the end of february and usually only has 3 or 4 seizures a month. It was stated that the patient had to take off work due to the seizures and reported having 10 seizures this month. The patient also reported having a ringing in his ear and stated it was at the time of his seizure. It was noted that he believes he had two night seizures. The patient reported that this was unusual for him as he has not had night seizures since he was young. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00495 |
| MDR Report Key | 9868475 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-05-20 |
| 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 | PULSE GEN MODEL 1000 |
| Generic Name | GENERATOR |
| Product Code | LYJ |
| Date Received | 2020-03-23 |
| Model Number | 1000 |
| Lot Number | 204907 |
| 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 | 1. Other | 2020-03-23 |