FDA Adverse Event
Injury
Summary report: N
STARFISH 2 HEART POSITIONER
MDR report key: 502641
·
Received December 19, 2003
Report
- Report Number
- 2135394-2003-00007
- Event Type
- Injury
- Date Received
- December 19, 2003
- Date of Event
- November 19, 2003
- Report Date
- November 19, 2003
- Manufacturer
- MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
- Product Code
- DWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INFO RECEIVED INDICATES THAT DURING AN OFF-PUMP CASE THE DEVICE WAS RELEASED AND PT BLEEDING WAS NOTED. THE CASE WENT TO BYPASS TO REPAIR PT CARDIAC TISSUE DAMAGE, WHICH ACCORDING TO INFO RECEIVED, WAS AT OR NEAR THE SITE WHERE THE UNIT HAD BEEN ATTACHED. LATER THE SAME DAY THE PT WAS REPORTED TO REQUIRE ADD'L SURGERY FOR BLEEDING. NO ADD'L CONSEQUENCE WAS REPORTED FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARFISH 2 HEART POSITIONER | HEART POSITIONER | DWS | MEDTRONIC CARDIAC SURGERY TECHNOLOGIES | 29800 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |