FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1032197
·
Received April 21, 2008
Report
- Report Number
- 2950887-2008-02096
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Report Date
- February 15, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE REFERENCE: REMES-TROCHES JM, ET AL. "PERFORMANCE, TOLERABILITY, AND SYMPTOMS RELATED TO PROLONGED PH MONITORING USING THE BRAVO SYSTEM IN MEXICO". AM J GASTROENTEROL 2005; 100:1-5. EIGHTY-FOUR PTS WERE STUDIED TO EVALUATE PERFORMANCE TOLERABILITY, AND SYMPTOMS RELATED TO A CATHETER-FREE PH MONITORING SYS (BRAVO). THE CAPSULE DID NOT ATTACH PROPERLY DURING THE FIRST ATTEMPT IN FOUR PTS AND THE PROCEDURE WAS ABANDONED. THE PTS SUBSEQUENTLY UNDERWENT SUCCESSFUL PH MONITORING WITH A TRANSNASAL CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BRAVO | FFT | MEDTRONIC NEUROMODULATION | 9012B1001 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |