FDA Adverse Event
Injury
Summary report: N
ENDOTAK C
MDR report key: 3240084
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-10985
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- May 31, 2013
- Report Date
- May 31, 2013
- Manufacturer
- HISTORICAL CPI ST. PAUL
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- 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 EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS SURGICALLY ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 339533 | ENDOTAK C | IMPLANTABLE LEAD | NVY | HISTORICAL CPI ST. PAUL | 0064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Hospitalization| L| R | 1857| 0064| 1705| 1786| 0293| E140 |