FDA Adverse Event
Malfunction
Summary report: N
ENTERRA II IPG
MDR report key: 20129727
·
Received September 3, 2024
Report
- Report Number
- 3027386225-2024-00103
- Event Type
- Malfunction
- Date Received
- September 3, 2024
- Date of Event
- August 7, 2024
- Report Date
- August 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
THE PATIENT REPORTED A DECREASE IN SYMPTOM RELIEF TO THE MANAGING PHYSICIAN, WHO THEN REFERRED HER TO AN ENTERRA SURGEON FOR EVALUATION. DURING THE SURGICAL PROCEDURE, IT WAS NOTED THAT THE LEADS OF THE ENTERRA DEVICE WERE TWISTED UPON THEMSELVES SEVERAL TIMES, APPEARING TIGHTLY COILED TOGETHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 717865 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Unknown | Other |