FDA Adverse Event
Malfunction
Summary report: N
ENTERRA II IPG
MDR report key: 19714582
·
Received July 10, 2024
Report
- Report Number
- 3027386225-2024-00059
- Event Type
- Malfunction
- Date Received
- July 10, 2024
- Date of Event
- May 31, 2024
- Report Date
- June 20, 2024
- Manufacturer
- ENTERRA MEDICAL, INC.
- Product Code
- LNQ
- UDI-DI
- 00763000449704
- PMA / PMN Number
- H990014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT SAW DR. (B)(6) ON (B)(6) 2024 TO HAVE HER DEVICE INTERROGATED AND IT WAS "OFF". ONLY THING THE PATIENT COULD RECALL AS POTENTIALLY HOW THAT WOULD HAPPEN WAS BEING AT A BEST BUY DURING AN ELECTRICAL SURGE DURING A STORM. PATIENT DID NOT REPORT FEELING ANY SENSATION AT THAT TIME. PATIENT EXPERIENCED A POWER SURGE WHILE OUT IN PUBLIC AND THE EVENT MAY HAVE INADVERTENTLY TURNED OFF THE DEVICE. DEVICE HAS SINCE BEEN TURNED ON AND PATIENT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2150028 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Other |