FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3052686
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-04323
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 28, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE. THE AMPLITUDE DROPPED AND NOISE WAS ALSO NOTED. THE PATIENT IS NOT DEPENDENT AND EXPERIENCED NO SYMPTOMS. THE FIELD REPRESENTATIVE WILL BE DISCUSSING A POSSIBLE REVISION WITH THE PHYSICIAN. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH A NON BSC LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155504 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0185 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Hospitalization| L| R | 4470| T165| 0185 |