FDA Adverse Event
Injury
Summary report: N
ENDOTAK ENDURANCE
MDR report key: 3213137
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10453
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 31, 2013
- Report Date
- June 4, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 AND EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313148 | ENDOTAK ENDURANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |