FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK RELIANCE
MDR report key: 7981676
·
Received October 18, 2018
Report
- Report Number
- 2124215-2018-18397
- Event Type
- Malfunction
- Date Received
- October 18, 2018
- Date of Event
- August 9, 2017
- Report Date
- August 9, 2018
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- PMA / PMN Number
- P910073/S043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAS HIGH SHOCK LEAD IMPEDANCE (SLI). THE RV LEAD IMPEDANCE MEASUREMENTS HAD BEEN AROUND 100-127 OHMS FOR ABOUT A YEAR. TECHNICAL SERVICES DISCUSSED POSSIBLE TROUBLESHOOTING OPTIONS. THE PHYSICIAN WAS GOING TO DECIDE OVER A COMMANDED SHOCK OR LEAD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 822125 | ENDOTAK RELIANCE | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |