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 104 manufactured by Cyberonics - Houston.
[186195232]
A generator was received into analysis due to an unknown reason. Follow up with the sender revealed the generator was explanted and returned due to the generator being exposed. It was stated the lead and generator were removed as the patient began having a reaction at the wound site, leading to the site having healing issues, later leading to the tissue break down and device becoming exposed. It was stated there was no infection per the notes. Information was received that the cause of the reaction at the wound site leading to healing issues and tissue break and eventual extrusion was related to the vns surgery. It was noted the "patient has had multiple replacements and skin thinning". Generator analysis was complete and no anomalies were found. No additional relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00517 |
| MDR Report Key | 9890654 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-11-26 |
| 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 104 |
| Generic Name | GENERATOR |
| Product Code | LYJ |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 104 |
| Lot Number | 204713 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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; 2. Required No Informationntervention | 2020-03-27 |