FDA Adverse Event
Death
Summary report: N
ENTERRA II IPG
MDR report key: 22372442
·
Received July 1, 2025
Report
- Report Number
- 3027386225-2025-00074
- Event Type
- Death
- Date Received
- July 1, 2025
- Date of Event
- January 29, 2025
- Report Date
- June 4, 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
PATIENT DEATH. PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. CHECKED IN AT MDT (B)(6) 2025. MDT RECORD ID: (B)(4). AS REPORTED EVENT DESCRIPTION: PATIENT DEATH. CAUSE OF DEATH: PENDING FURTHER STUDIES. (LEADS RECEIVED CONNECTED TO DEVICE AND SEGMENTED AT PROXIMAL END). REPORTED IN DATABASE ONLY; WAITING FOR DEVICE ANALYSIS FROM MDT. DEVICE EXPLANTED AS A RESULT OF PATIENT DEATH. NO INDICATION THAT PATIENT DEATH WAS DUE TO DEVICE. NO FURTHER ACTION TO BE TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1381110 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |