FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 1944927
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-19675
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 1, 2010
- Report Date
- October 1, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A CLINICIAN STATED THAT THE RIGHT ATRIAL (RA) LEAD WAS GOING TO BE REVISED FOR AN UNKNOWN REASON. THE RA LEAD IN THIS PATIENT IS THE CRITICAL THERAPY LEAD. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION FROM THE HOSPITAL. NO 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 | 64 YR | Hospitalization| L| R | 1298| 4086 |