FDA Adverse Event
Injury
Summary report: N
DURAN RING
MDR report key: 3092508
·
Received May 3, 2013
Report
- Report Number
- 2025587-2013-00071
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 11, 2013
- Manufacturer
- HEART VALVES SANTA ANA
- Product Code
- KRH
- PMA / PMN Number
- D053610
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY RING, IMPLANTED 17 YEARS, WAS EXPLANTED DUE TO MITRAL REGURGITATION. IT WAS REPORTED THAT THE HOSPITAL MISPLACED THE PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194661 | DURAN RING | RING, ANNULOPLASTY | KRH | HEART VALVES SANTA ANA | 610R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Hospitalization| R |