FDA Adverse Event
Injury
Summary report: N
S FLEX/FEP 1X24 T31/CS6 3/ODA
MDR report key: 3122550
·
Received May 17, 2013
Report
- Report Number
- 9612501-2013-00045
- Event Type
- Injury
- Date Received
- May 17, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- COVIDIEN
- Product Code
- LDF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: CARDIAC SURGERY. ACCORDING TO THE REPORTER: DURING THE SET UP OF ELECTRODE THE NEEDLE TORN APART FROM THE SUTURE. THERE WAS ALSO A PROBLEM WITH DELAMINATION OF ELECTRODE JUST NEXT TO THE NEEDLE, WHICH CAUSED THE CARDIAC RUPTURE (THE SURGEON NEEDED TO USE ADD'L SUTURES). THE RUPTURE WAS FIXED WITH SUTURES. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219514 | S FLEX/FEP 1X24 T31/CS6 3/ODA | FLEXON | LDF | COVIDIEN | D2H1093X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |