FDA Adverse Event
Injury
Summary report: N
RELIANCE 4-FRONT?
MDR report key: 24248139
·
Received February 3, 2026
Report
- Report Number
- 2124215-2026-06056
- Event Type
- Injury
- Date Received
- February 3, 2026
- Date of Event
- December 28, 2025
- Report Date
- February 3, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVY
- UDI-DI
- 00802526592829
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS INVESTIGATION WILL BE UPDATED SHOULD PERTINENT INFORMATION BECOME AVAILABLE IN THE FUTURE.
Description of Event or Problem · 0
IT WAS REPORTED THAT A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS GOING TO BE PERFORMED ON THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT THE ICD SYSTEM EXHIBITED HIGH SHOCK LEAD IMPEDANCE MEASUREMENTS, REACHING OUT OF RANGE VALUES GREATER THAN 125 OHMS. THEREFORE, TS RECOMMENDED PROGRAMMING ADJUSTMENTS AND A REPORT OF THE NIPS RESULTS. THE FIELD REPRESENTATIVE CONFIRMED THAT THE NIPS WAS PERFORMED. THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313192 | RELIANCE 4-FRONT? | IMPLANTABLE LEAD | NVY | BOSTON SCIENTIFIC CORPORATION | 0672 | 199053 | 00802526592829 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Other |