ENDOTAK RELIANCE
Report
- Report Number
- 2124215-2016-17242
- Event Type
- Malfunction
- Date Received
- October 19, 2016
- Date of Event
- September 23, 2016
- Report Date
- October 18, 2016
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVY
- PMA / PMN Number
- P910073/S077
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE RECEIVED.
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED FLUCTUATING PACE IMPEDANCE MEASUREMENTS AT THE IMPLANT PROCEDURE WHEN CONNECTED TO A PACING SYSTEM ANALYZER (PSA). THE IMPEDANCE MEASUREMENTS JUMPED BETWEEN >2000 OHMS AND 800-900 OHMS AND STABILIZED AROUND 2000 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR ASSISTANCE AND ADVISED TO WAIT A FEW MINUTES AND TEST AGAIN. THIS LEAD WAS IMPLANTED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
ADDITIONAL INFORMATION INDICATES THE RIGHT VENTRICULAR (RV) LEAD PACE IMPEDANCE MEASUREMENT RETURNED TO VALUES IN ACCEPTABLE LIMITS (1787 OHMS) AND WAS SUCCESSFULLY IMPLANTED WITHOUT COMPLICATION. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690039 | ENDOTAK RELIANCE | NVY | CPI - DEL CARIBE | 0282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | 0282| 4671| 7736| G148 |