FDA Adverse Event
Death
Summary report: N
ENTERRA II IPG
MDR report key: 19712729
·
Received July 10, 2024
Report
- Report Number
- 3027386225-2024-00066
- Event Type
- Death
- Date Received
- July 10, 2024
- Date of Event
- January 19, 2024
- Report Date
- May 30, 2024
- 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
IN MEDTRONIC DATABASE: PATIENT DEATH WAS REPORTED. CAUSE OF DEATH WAS DIABETIC - KETOACIDOSIS. NOT DEVICE RELATED. DATE OF DEATH: (B)(6) 2024; DATE OF EXPLANT: (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2144528 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Male | Death |