FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2161573
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07253
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- February 13, 2011
- Report Date
- April 15, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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 THE PATIENT WITH THIS PACING SYSTEM DEVELOPED AN INFECTION. THE PATIENT'S BREASTBONE HAD TO BE REMOVED AND A FLAP WAS CREATED TO PROTECT HER HEART.
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 | 69 YR | Hospitalization| L| R | S606| 4088| 4087 |