FDA Adverse Event
Injury
Summary report: N
FLEXTEND
MDR report key: 2150977
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06151
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- April 4, 2011
- Report Date
- April 4, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P960006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WITH CURRENT INFORMATION, THE PRODUCT REMAINS IN SERVICE, HOWEVER IS SCHEDULED FOR EXPLANT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PRODUCT HAS A BACTEREMIA INFECTION. THE PRODUCT IS APART OF A SYSTEM THAT IS SCHEDULED FOR EXPLANT IN THE NEAR FUTURE DUE TO THIS INFECTION. NO ADDITIONAL ADVERSE PT EFFECTS HAVE BEEN 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 | 69 YR | Hospitalization| L| R | 4088| 4087| 4518| H125| 4525 |