FDA Adverse Event
Injury
Summary report: N
ENTERRA II IPG
MDR report key: 20055895
·
Received August 23, 2024
Report
- Report Number
- 3027386225-2024-00093
- Event Type
- Injury
- Date Received
- August 23, 2024
- Date of Event
- June 27, 2024
- Report Date
- July 18, 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
DEVICE RETURNED TO MEDTRONIC FOR ANALYSIS FOR AN UNKNOWN REASON. NO ANOMALIES DETECTED. NO FURTHER ACTION TO BE TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1618688 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |