FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3053603
·
Received April 11, 2013
Report
- Report Number
- 2124215-2013-05401
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 26, 2013
- Report Date
- March 26, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED LEAD WILL NOT BE RETURNED. 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 MEASUREMENTS. THE LEAD WAS CONFIRMED TO BE DISLODGED. THE LEAD WAS THEN EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155867 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |