FDA Adverse Event
Malfunction
Summary report: N
ENTERRA II IPG
MDR report key: 19722277
·
Received July 11, 2024
Report
- Report Number
- 3027386225-2024-00076
- Event Type
- Malfunction
- Date Received
- July 11, 2024
- Date of Event
- May 24, 2024
- Report Date
- July 1, 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
PT HAD ABNORMAL LEAD IMPEDANCE AT TIME OF OF SURGERY FOR A BATTERY CHANGE. THE SURGEON SUSPECTS THERE IS SOMETHING DAMAGED WITH ONE OF THE LEADS. SURGEON PLANS TO TAKE PATIENT BACK TO SURGERY AND DO EXPLORATORY LAP AND THEN POTENTIALLY REPLACE LEADS. FOLLOW-UP: PATIENT HAD EXPLORATORY LAP AND SURGEON DECIDED TO REPLACE BOTH LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2380831 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Female | Other |