FDA Adverse Event
Injury
Summary report: N
TALENT TAA
MDR report key: 3162510
·
Received June 11, 2013
Report
- Report Number
- 2953200-2013-01093
- Event Type
- Injury
- Date Received
- June 11, 2013
- Report Date
- May 14, 2013
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P070007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: PARALYSIS. CAUSE IS UNKNOWN. CONCLUSIONS: CAUSE IS UNKNOWN.
Description of Event or Problem · 1
A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SOME PARALYSIS AFTER THE STENTS WERE PUT IN. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 262534 | TALENT TAA | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND | V00529122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |