FDA Adverse Event
Malfunction
Summary report: N
RELIANCE 4-FRONT
MDR report key: 19632486
·
Received June 28, 2024
Report
- Report Number
- 2124215-2024-39896
- Event Type
- Malfunction
- Date Received
- June 28, 2024
- Date of Event
- June 18, 2024
- Report Date
- June 28, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526592829
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS PRESENTING A RETROGRADE CONDUCTION AND NON-CONDUCTED PREMATURE ATRIAL CONTRACTIONS. THIS ICD WAS FREQUENTLY PACING WHEN IT WAS SUPPOSED TO BE SET TO NOT PACE TECHNICAL SERVICES (TS) WAS CONSULTED ABOUT CROSS TALK PRESENT ON THE RIGHT VENTRICULAR (RV) LEAD AND GAVE TROUBLESHOOTING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2184304 | RELIANCE 4-FRONT | IMPLANTABLE LEAD | LWS | BOSTON SCIENTIFIC CORPORATION | 0672 | 248763 | 00802526592829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |