FDA Adverse Event
Death
Summary report: N
ENTERRA II IPG
MDR report key: 22371303
·
Received July 1, 2025
Report
- Report Number
- 3027386225-2025-00081
- Event Type
- Death
- Date Received
- July 1, 2025
- Date of Event
- May 12, 2025
- Report Date
- June 6, 2025
- Manufacturer
- ENTERRA MEDICAL, INC.
- Product Code
- LNQ
- UDI-DI
- 00763000449704
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS: REPORTED IN MEDTRONIC DATABASE. RECEIVED FROM (B)(6) IN (B)(6). CODED AS C-500 NON-COMPLAINT AT MEDTRONIC AND CLOSED. ORIGINALLY IMPLANTED ON (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1261802 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |