FDA Adverse Event
Malfunction
Summary report: N
ENTERRA II IPG
MDR report key: 19711831
·
Received July 10, 2024
Report
- Report Number
- 3027386225-2024-00063
- Event Type
- Malfunction
- Date Received
- July 10, 2024
- Date of Event
- May 7, 2024
- Report Date
- May 29, 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
NT REPORTS THAT A LEAD HAS POPPED OUT AND IS SHOCKING THEM AND CAUSING PAIN. THEY NEED TO FIND A LOCAL DOCTOR/SURGEON WHO CAN FIX IT ASAP. THEY HAVE 90% OF THEIR COLON REMOVED AND BLADDER ISSUES AND WHEN THEY TURN IT OFF, THEY CANT GO TO THE BATHROOM LIKE A NORMAL PERSON WHICH IN TURN CAUSES THEIR GASTROPARESIS TO FLARE UP REALLY BAD. THIS IS A SEMI-EMERGENCY SITUATION BECAUSE THE PATIENT CANT FUNCTION NORMALLY WITH IT NOT WORKING PROPERLY. HAVE TRIED TO FOLLOW-UP WITH PATIENT REPEATEDLY, WITH NO REPLY RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363957 | ENTERRA II IPG | GASTRIC STIMULATOR | LNQ | ENTERRA MEDICAL, INC. | 37800 | 00763000449704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |