FDA Adverse Event
Injury
Summary report: N
SOLOGRIP III HANDPIECE
MDR report key: 3700740
·
Received March 26, 2014
Report
- Report Number
- 2950727-2014-00004
- Event Type
- Injury
- Date Received
- March 26, 2014
- Date of Event
- November 29, 2013
- Report Date
- March 21, 2014
- Manufacturer
- CARDIOGENESIS CORPORATION
- Product Code
- MNO
- PMA / PMN Number
- P970029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Additional Manufacturer Narrative · 1
THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON DAY 2 AFTER THE TMR PROCEDURE. THE PATIENT WAS ANGINA-FREE AT 30 DAYS. ACCORDING TO DOCUMENTATION, ALL AVAILABLE RECORDS SHE THE HANDPIECE WAS CORRECTLY ASSEMBLED FROM APPROVED COMPONENTS AND WERE INSPECTED TO SPECIFICATIONS. ATRIAL FIBRILLATION IS A COMMON EARLY ADVERSE EVENT AFTER CORONARY ARTERY BYPASS GRAFT PROCEDURES WITH OUR WITHOUT ADJUNCTIVE TMR. THIS IS NOT UNEXPECTED EVENT TWO DAYS AFTER THE PROCEDURE.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON DAY 2 AFTER THE TMR PROCEDURE.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED ATRIAL FIBRILLATION ON DAY 2 AFTER THE TMR PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 178461 | SOLOGRIP III HANDPIECE | TRANSMYOCARDIAL REVASCULARIZATION LASER HANDPIECE | MNO | CARDIOGENESIS CORPORATION | HP-SG3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other |