FDA Adverse Event
Death
Summary report: N
ENTERRA II IPG
MDR report key: 19715655
·
Received July 10, 2024
Report
- Report Number
- 3027386225-2024-00067
- Event Type
- Death
- Date Received
- July 10, 2024
- Date of Event
- May 9, 2022
- Report Date
- September 29, 2025
- Manufacturer
- ENTERRA MEDICAL, INC.
- Product Code
- LNQ
- UDI-DI
- 00763000449704
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE RETURNED FROM PATHOLOGIST, (B)(6). PATIENT (B)(6) AGE 35. PATHOLOGIST STATED DEATH WAS UNRELATED TO DEVICE.
Description of Event or Problem · 0
REPORTED IN MEDTRONIC DATABASE: PATIENT DEATH UNRELATED TO DEVICE WAS REPORTED, NO ADDITIONAL DETAILS SURROUNDING CAUSE OF DEATH. DATE OF EXPLANT: ON (B)(6) 2022. DATE OF DEATH: ON (B)(6) 2022. TESTING OF RETURNED DEVICE REVEALED THAT THE IPG BATTERY WAS DEAD. UNABLE TO OBTAIN ANY OTHER INFORMATION. NO REASON TO SUSPECT THAT PATIENT DEATH WAS RELATED TO DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 354980 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Unknown | Death |