MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-11-16 for BRAVO 9012B1001 NA manufactured by Arizona Device Manufacturing.
[15613330]
See also manufacturer reports 2032545-2007-03918 and 2032545-2007-03919. The hcp reported that while placing a bravo ph monitor, the capsule attached to the patient's esophagus, but did not deploy from the delivery system. The capsule was pulled off of the esophagus upon removal of the delivery system from the patient. Two other attempts were made with new devices which had the same failure. This was the third and last attempt and this time the plunger was rotated until it broke. Assistance was requested by the physician for the next case. The patient experienced minor bleeding which required no medical intervention.
Patient Sequence No: 1, Text Type: D, B5
[15929469]
To date, the device has not been returned to medtronic for evaluation. If further information is received or the device returned, a follow-up medwatch report will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032545-2007-03920 |
| MDR Report Key | 949628 |
| Report Source | 05 |
| Date Received | 2007-11-16 |
| Date of Report | 2007-10-17 |
| Date of Event | 2007-10-16 |
| Date Mfgr Received | 2007-10-17 |
| Device Manufacturer Date | 2007-09-04 |
| Date Added to Maude | 2008-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MICHELLE BUDINGER |
| Manufacturer Street | 710 MEDTRONIC PARKWAY NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635050811 |
| Manufacturer G1 | ARIZONA DEVICE MANUFACTURING |
| Manufacturer Street | 2350 WEST MEDTRONIC WAY |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVO |
| Product Code | FTT |
| Date Received | 2007-11-16 |
| Model Number | 9012B1001 |
| Catalog Number | NA |
| Lot Number | Q203946 |
| ID Number | 4518 |
| Device Expiration Date | 2008-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 946152 |
| Manufacturer | ARIZONA DEVICE MANUFACTURING |
| Manufacturer Address | 2350 WEST MEDTRONIC WAY TEMPE AZ 85281 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-16 |