FDA Adverse Event
Malfunction
Summary report: N
ENTERRA II IPG
MDR report key: 19877960
·
Received July 31, 2024
Report
- Report Number
- 3027386225-2024-00081
- Event Type
- Malfunction
- Date Received
- July 31, 2024
- Date of Event
- June 25, 2024
- Report Date
- July 11, 2024
- Manufacturer
- ENTERRA MEDICAL, INC.
- Product Code
- LNQ
- 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 ORIGINALLY IMPLANTED ON (B)(6) 2022 AND WELL CONTROLLED WITH ENTERRA. A FEW WEEKS AGO THE PATIENT STARTED NOTICING A RETURN OF SYMPTOMS AND A SHOCKING SENSATION. WHEN HE WAS INTERROGATED, THE IMPEDENCE WAS OUT OF RANGE (HIGH) AND HE WAS SCHEDULED FOR A LEAD REVISION. ONCE LEADS WERE REPLACED, THE IMPEDENCE IS IN NORMAL RANGE. LEADS WERE EXHIBITING HIGH IMPEDANCE; NOT RETURNED FOR ANALYSIS. PATIENT IS DOING FINE AFTER NEW LEADS IMPLANTED. NO FURTHER ACTION TO BE TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1240138 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Male | Other |