FDA Adverse Event
Injury
Summary report: N
ENTERRA II IPG
MDR report key: 19730116
·
Received July 12, 2024
Report
- Report Number
- 3027386225-2024-00069
- Event Type
- Injury
- Date Received
- July 12, 2024
- Date of Event
- June 10, 2024
- Report Date
- June 21, 2024
- Manufacturer
- ENTERRA MEDICAL, INC.
- Product Code
- LNQ
- UDI-DI
- 00763000449704
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT WAS EXPERIENCING SHOCKING AND REQUESTED TO HAVE LEADS CHANGED OUT. PHYSICIAN CHANGED OUT LEADS AND BATTERY. PATIENT EXPERIENCED SHOCKING SENSATIONS THEREFORE IPG AND LEADS WERE REPLACED. PATIENT IS NOW DOING FINE. NO FURTHER ACTION TO BE TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271330 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Unknown | Other |