FDA Adverse Event
Injury
Summary report: N
ENDOTAK ENDURANCE
MDR report key: 3953783
·
Received July 23, 2014
Report
- Report Number
- 2124215-2014-13593
- Event Type
- Injury
- Date Received
- July 23, 2014
- Date of Event
- June 26, 2014
- Report Date
- June 26, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- 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. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431578 | ENDOTAK ENDURANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| L| R | E110| 0155| 4087| 1861 |