FDA Adverse Event
Injury
Summary report: N
ENTERRA II IPG
MDR report key: 20292175
·
Received September 24, 2024
Report
- Report Number
- 3027386225-2024-00109
- Event Type
- Injury
- Date Received
- September 24, 2024
- Date of Event
- August 25, 2024
- Report Date
- September 3, 2024
- Manufacturer
- ENTERRA MEDICAL, INC.
- Product Code
- LNQ
- UDI-DI
- 00763000449704
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
PATIENT REPORTING OF FEELING SHOCKS THROUGHOUT HIS BODY DURING MRI. PATIENT WAS AT (B)(6) WAS SCHEDULED FOR A MRI OF HIS FOOT. A PROGRAMMER WAS SENT AND THE DEVICE WAS TURNED OFF. HOSPTIAL USED A GE SEND AND RECEIVE COIL. THE HOSPITAL FOLLOWED OUR PROCEDURES WITHIN OUR MRI MANUAL. 1.5 TESLA MRI WAS USED. PATIENT SAID THAT THE SENSATION HE WAS FEELING WAS OVER HIS WHOLE BODY. HE ALSO SAID THE SHOCKING HE WAS FEELING WAS NOT AROUND THE LOCATION OF THE DEVICE. AFTER THE MRI WAS ATTEMPTED, I REACHED OUT TO (B)(6) AND HAD A NURSE WHO WAS ON PATIENT'S FLOOR, WE CONFIRMED THAT THE DEVICE WAS TURNED OFF, WITH THE FOLLOWING SETTINGS: 488 OHMS, 5 V, CURRENT 10.2 MA, PULSE WIDTH 330, RATE (B)(4), ON .1 SEC, OFF 5 SEC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1877973 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Male | Other |