N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908576
- MDR report key
- 9908576
- Report number
- 9710107-2020-00180
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-11
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- AMY BEEMAN
- Address
- 161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US
- Phone
- 763-763-7632
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BRAVO | ELECTRODE, PH, STOMACH | GIVEN IMAGING LTD., YOQNEAM | FFT | FGS-0313 | FGS-0313 | 46935Q | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, THE CAPSULE FAILED TO TRANSMIT. THE CAPSULE WAS CALIBRATED THEN PLACED, AND THE RECORDER STATUS SHOWED "SEARCHING FOR CAPSULE". THE CUSTOMER SELECT CANCEL AND RESTART THE RECORDER, THEN SELECT START STUDY, BUT THE RECORDER STILL FAILED TO DETECT THE CAPSULE. THE CUSTOMER USED A SECOND RECORDER, BUT IT ALSO FAILED TO SEARCH THE CAPSULE. THE CAPSULE STOPPED TRANSMITTING AFTER PLACEMENT. THERE WAS NO PATIENT AND USER HARM.