FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3904326
·
Received July 1, 2014
Report
- Report Number
- 2124215-2014-11987
- Event Type
- Malfunction
- Date Received
- July 1, 2014
- Date of Event
- February 3, 2012
- Report Date
- April 5, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR
- 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 HAD EXHIBITED A GRADUALLY INCREASED PACING IMPEDANCE MEASUREMENTS, ULTIMATELY MEASURING GREATER THAN 2,000 OHMS. ALL OTHER LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. THE LOCAL AREA SALES REPRESENTATIVE REPORTED THAT THE PATIENT WOULD CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385108 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0148 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | 0148| N119| 4136| 1860| 4554 |