FDA Adverse Event
Injury
Summary report: N
ENDOTAK ENDURANCE
MDR report key: 2050391
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-03519
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 RIGHT VENTRICULAR (RV) LEAD WAS CUT AND SURGICALLY ABANDONED DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE. A TEMPORARY PACEMAKER WAS SUCCESSFULLY IMPLANTED ON THE PATIENT'S RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK ENDURANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Life Threatening| R | 0062| E110| 4086| 4136| S401| 0154| 1746| 1861| 1850 |