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 2020-03-24 for PULSE GEN MODEL 105 manufactured by Cyberonics - Houston.
[184683584]
It was reported that the patient's skin over the generator was thin and starting to turn grey. The surgeon indicated that the skin was wearing away; therefore, the generator was repositioned. No other relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1644487-2020-00497 |
| MDR Report Key | 9872307 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2017-11-07 |
| Date Added to Maude | 2020-03-24 |
| 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 105 |
| Generic Name | GENERATOR |
| Product Code | LYJ |
| Date Received | 2020-03-24 |
| Model Number | 105 |
| Lot Number | 5504 |
| Device Expiration Date | 2019-10-17 |
| 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 | 2020-03-24 |