FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1032203
·
Received April 21, 2008
Report
- Report Number
- 2950887-2008-02097
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- January 1, 2004
- Report Date
- February 15, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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: BHAT YM, MCGRATH KM, BIELEFELDT K, WIRELESS ESOPHAGEAL PH MONITORING: NEW TECHNIQUE MEANS NEW QUESTIONS. J CLIN GASTROENTEROL 2006; 40(2): 116-121. TWO HUNDRED-SEVENTEEN PTS ENROLLED IN A RESEARCH REGISTRY TO ASSESS THE FEASIBILITY AND SAFETY OF WIRELESS PH MONITORING OVER A 12 MO PERIOD. ONE PT HAD A SECOND CAPSULE INSERTED DURING THE SAME SESSION BECAUSE THE FIRST CAPSULE DID NOT SUCCESSFULLY RELEASE DURING THE INITIAL ATTEMPT.
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 |