FDA Adverse Event
Injury
Summary report: N
BRAVO
MDR report key: 1037248
·
Received May 1, 2008
Report
- Report Number
- 2950887-2008-02353
- Event Type
- Injury
- Date Received
- May 1, 2008
- Report Date
- March 28, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- FFT
- PMA / PMN Number
- K002028
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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: 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 IN 2005 WITH TELEMETRIC CAPSULE. THE PATIENT EXPERIENCED MODERATE TRANSITORY (<72 HOURS) DYSPHASIA. THE SUTURE DID NOT HOLD FOR THE FIRST CAPSULE; THE PLUNGER MOVING THE PIN WAS NOT INSERTED UP TO THE HUB BECAUSE OF TORN MUCOSA AT THE ATTACHMENT SITE. A SECOND CAPSULE WAS PUT IN PLACE.
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 | Required Intervention |