MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-10-27 for BRAVO 9012B1001 manufactured by Medtronic, Inc..
[18489686]
The hcp reported that while attempting to perform a bravo procedure, the capsule attached to the tissue, but failed to detach from the delivery system. A biopsy forceps was used to release the tissue allowing the delivery system to be removed. There was no bleeding or other adverse affects to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[18725921]
To date, medtronic inc. Has not received the device 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 | 9613232-2004-01410 |
| MDR Report Key | 904380 |
| Report Source | 05 |
| Date Received | 2004-10-27 |
| Date of Report | 2004-09-28 |
| Date of Event | 2004-09-28 |
| Date Added to Maude | 2007-08-30 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARIE HOLM |
| Manufacturer Street | 400 LEXINGTON AVENUE NORTH |
| Manufacturer City | SHOREVIEW MN 55126 |
| Manufacturer Country | US |
| Manufacturer Postal | 55126 |
| Manufacturer Phone | 8003280810 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | * |
| Manufacturer City | SKOVLUNDE |
| Manufacturer Country | DA |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BRAVO |
| Generic Name | UNK |
| Product Code | FTT |
| Date Received | 2004-10-27 |
| Model Number | 9012B1001 |
| Catalog Number | 9012B1001 |
| Lot Number | 040494 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 879194 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | * SKOVLUNDE DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-10-27 |