FDA Adverse Event
Malfunction
Summary report: N
BRAVO
MDR report key: 1037570
·
Received May 1, 2008
Report
- Report Number
- 2950887-2008-02355
- Event Type
- Malfunction
- Date Received
- May 1, 2008
- Report Date
- March 28, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE REFERENCE: J LETARD, ET AL. WIRELESS ESOPHAGEAL PH MONITORING: TECHNICAL ASPECT. ACTA ENDOSCOPICA. 2006; 36(2): 163-165. THE ARTICLE DISCUSSES THE RESULTS OF TWENTY-TWO PATIENTS WHO WERE IMPLANTED BETWEEN MARCH 2005 AND SEPTEMBER 2005 WITH TELEMETRIC CAPSULE. ONE PATIENT SUFFERED IMPLANT FAILURE DUE TO BREAKAGE OF THE PLASTIC WINGS SITUATED IN THE HANDLE, WHICH SERVE AS STOPS DURING THE FINAL ROTATION OF THE PLUNGER, CAUSED BY AN ERROR IN MANIPULATION. THE SYSTEM WAS IMPACTED AT THE WALL AND THE MUCOSA HAD TO BE TORN SUPERFICIALLY WITHOUT CONSEQUENCE.
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 |