FDA Adverse Event
Malfunction
Summary report: N
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE)
MDR report key: 2844398
·
Received November 5, 2012
Report
- Report Number
- 2024601-2012-01140
- Event Type
- Malfunction
- Date Received
- November 5, 2012
- Date of Event
- August 27, 2012
- Report Date
- October 9, 2012
- Manufacturer
- ALLERGAN
- Product Code
- LTI
- PMA / PMN Number
- P000008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT TO FDA ON: (B)(4) 2012. ALLERGAN HAS RECEIVED THE PRODUCT, HOWEVER, THE DEVICE HAS NOT BEEN IDENTIFIED NOR HAS THE ANALYSIS BEEN COMPLETED AT THIS TIME. BASED UPON THE MODEL NUMBER, SERIAL NUMBER AND IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER II. VISUAL EXAMINATION MAY DETERMINE THE CONNECTOR TYPE ASSOCIATED WITH THIS REPORT. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OR THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTED A LAP-BAND PORT "LEAK." A FLUOROSCOPY WAS CONDUCTED THAT NOTED A LEAK AT THE BOTTOM OF THE PORT. THE PORT WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (LARGE) | LTI | ALLERGAN | NA | 1740831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | METHOCARBAMOL| GABAPENTIN |