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 2020-03-27 for PULSE GEN MODEL 1000 manufactured by Cyberonics - Houston.
[186194125]
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
Patient Sequence No: 1, Text Type: N, H10
[186194126]
It was reported by surgeon that patient is being explanted due to an open wound at unspecified location. Information was later received that open wound was located at generator site and was caused by an infection. The physician does not know the cause of the infection. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. Design history record review for the generator performed. The generator was confirmed to have been sterilized prior to distribution into the field. The device passed all specifications. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00499 |
| MDR Report Key | 9888467 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-01-23 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | 1000 |
| Lot Number | 204775 |
| 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. Required No Informationntervention | 2020-03-27 |