FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1954105
·
Received January 10, 2011
Report
- Report Number
- 2124215-2010-24298
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PERFORATION BY THIS RECENTLY-IMPLANTED RIGHT ATRIAL LEAD WAS SUSPECTED TO BE THE CAUSE OF PERICARDIAL EFFUSION AND PERICARDITIS EXPERIENCED BY THE PATIENT. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE PATIENT HAD PRESENTED TO AN EMERGENCY ROOM EIGHT DAYS AFTER IMPLANT, WHERE AN X-RAY AND ECHOCARDIOGRAM WERE PERFORMED. THE PATIENT WAS HOSPITALIZED TO MONITOR THIS ISSUE AND OTHER NON-DEVICE RELATED MEDICAL ISSUES THE PATIENT IS EXPERIENCING. THE PHYSICIAN¿S INTENT IS TO ADDRESS THE EFFUSION/PERICARDITIS IN APPROXIMATELY TWO WEEKS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXTEND | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| L | S603| 4087| 4086 |