FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3922072
·
Received July 9, 2014
Report
- Report Number
- 2124215-2014-12963
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- June 7, 2014
- Report Date
- June 7, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT AS OBSERVED VIA REMOTE PATIENT MONITORING SYSTEM. OVERSENSING OF NOISE WAS NOTED BUT DID NOT LEAD TO PACING INHIBITION. NOISE WAS REPRODUCIBLE WITH ISOMETRICS AND POCKET MANIPULATION. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE WAS NOT DETERMINED. THIS LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401678 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Hospitalization| L| R | 4135| 0180| E110 |