FDA Adverse Event
Injury
Summary report: N
SELUTE
MDR report key: 3240118
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-09682
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- May 21, 2013
- Report Date
- May 21, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- PMA / PMN Number
- P950001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT HAD ENDOCARDITIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. ALL AVAILABLE INFORMATION RECEIVED INDICATES THAT THE PRODUCT WAS SURGICALLY ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339807 | SELUTE | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4285 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| L| R | 1296| 0185| 4285| 0976| 1388TC| 4554| H170| 4440 |