FDA Adverse Event
Malfunction
Summary report: N
LAGB VG ADJUSTABLE GASTRIC BANDING SYSTEM
MDR report key: 1749758
·
Received June 11, 2010
Report
- Report Number
- 1749758
- Event Type
- Malfunction
- Date Received
- June 11, 2010
- Date of Event
- October 1, 2009
- Report Date
- June 11, 2010
- Manufacturer
- ALLERGAN, INC.
- Product Code
- LTI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IA, US
Narratives
Description of Event or Problem · 1
THE PT HAD A LAP BAND PORT PLACED SURGICALLY THREE YEARS AGO. THE PT SUBSEQUENTLY DEVELOPED DYSPHAGIA AND A GASTRIC PROLAPSE WHILE INNER-TUBING LAST YEAR. THE SURGEON THINKS THE LAPAROSCOPIC ADJUSTABLE GASTRIC BAND SLIPPED AND A MONTH LATER IT DID NOT REDUCE WITH THE REMOVAL OF FLUID. THE SURGEON RECOMMENDED THE REMOVAL OF THE BAND AT THAT TIME BUT DUE TO FINANCIAL ISSUES, THE PT DID NOT PROCEED. THE PT BECAME ACUTELY WORSE WITH DYSPHAGIA AND PAIN THE LAST 24 HOURS PRIOR TO ADMISSION. THE SURGEON REMOVED HER LAPAROSCOPIC ADJUSTABLE BAND AND PORT. SHE HAD NO COMPLICATIONS AND WAS DISCHARGED HOME. THE MFR WILL SEND AN EXPLANT KIT FOR THE DEVICE TO BE RETURNED FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAGB VG ADJUSTABLE GASTRIC BANDING SYSTEM | GASTRIC BUBBLE, LAP BAND SYSTEM | LTI | ALLERGAN, INC. | * | M49911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |