FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 1944717
·
Received January 3, 2011
Report
- Report Number
- 2124215-2010-21946
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS SUCCESSFULLY REPOSITIONED. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. 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 DEFIBRILLATION LEAD REQUIRED REPOSITIONING ONE DAY POST IMPLANT DUE TO DISLODGEMENT. IT WAS REPORTED THAT THE PATIENT WITH THIS LEAD IS NOT PACEMAKER DEPENDENT AND THAT NO OTHER ADVERSE PATIENT EFFECTS WERE OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |