FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3041310
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-01465
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 9, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- 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, DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE FRACTURED AT THE CLAVICULAR LINE. AN INSULATION BREAKDOWN WAS ALSO NOTED WHICH RESULTED IN PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS THROUGH THE OLD DEVICE AND WAS 140 OHMS THROUGH THE PACING SYSTEM ANALYZER (PSA). THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143038 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | NVY | CPI - DEL CARIBE | 0158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Hospitalization| L| R | N140| T165| 4543| 4470| 0286| 0158 |