FDA Adverse Event
Malfunction
Summary report: N
LAUNCHER 6F (EBU4.0)
MDR report key: 2033060
·
Received February 25, 2011
Report
- Report Number
- 1220452-2011-00011
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 4, 2011
- Manufacturer
- MEDTRONIC INC.
- Product Code
- DQY
- PMA / PMN Number
- K21256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. (B)(4) DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE, THE SHAFT BROKE IN TWO PIECES. ALL OF THE PIECES WERE REMOVED FROM THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAUNCHER 6F (EBU4.0) | DQY | MEDTRONIC INC. | NA | 0004670657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |