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 2020-02-14 for PULSE GEN MODEL 106 manufactured by Cyberonics - Houston.
[179456598]
Device evaluated by mfr? , device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
Patient Sequence No: 1, Text Type: N, H10
[179456599]
It was reported that the patient had a battery replacement and all went well. The implant card was received and indicated the reason for replacement was due to wound revision. It is unknown at this time if there was an issue with the generator wound site. Device history record's for the generator was reviewed. The generator passed final quality and functional specifications prior to release. The device was sterilized prior to being distributed. Per the facility the surgery took place, all explants are discarded during surgery. 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. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00252 |
| MDR Report Key | 9711710 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2020-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 106 |
| Generic Name | GENERATOR |
| Product Code | MUZ |
| Date Received | 2020-02-14 |
| Model Number | 106 |
| Lot Number | 5112 |
| Device Expiration Date | 2018-11-01 |
| 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 | 2020-02-14 |