FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2171591
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-10364
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- December 9, 2009
- Report Date
- June 6, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THIS LEAD WAS EXPLANTED AND REPLACED WITH A NEW RIGHT ATRIAL (RA) LEAD. 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 | 4087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Life Threatening| R | 4087| S606| 4088 |