INGENIO
Report
- Report Number
- 2124215-2024-81752
- Event Type
- Malfunction
- Date Received
- December 24, 2024
- Date of Event
- December 17, 2024
- Report Date
- January 21, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. THE ASSOCIATED INVESTIGATION DETERMINED THAT THIS DEVICE EXHIBITED INTERMITTENT FLUCTUATIONS IN IMPEDANCE MEASUREMENTS WITH NO CONCLUSIVE EVIDENCE OF A PRODUCT PERFORMANCE ISSUE; PLEASE REFER TO THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT.
IT WAS REPORTED THAT THIS PACEMAKER SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) ALERT DUE TO HIGH OUT-OF-RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCES, MEASURING BETWEEN 1600 AND 2000 OHMS. CONTINUED MONITORING AND FOLLOW-UP WERE PLANNED, AS LEAD FAILURE WAS SUSPECTED. THE RV LEAD IS A NON-BOSTON SCIENTIFIC DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.
IT WAS REPORTED THAT THIS PACEMAKER SYSTEM TRIGGERED A LEAD SAFETY SWITCH (LSS) ALERT DUE TO HIGH OUT-OF-RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCES, MEASURING BETWEEN 1600 AND 2000 OHMS. CONTINUED MONITORING AND FOLLOW-UP WERE PLANNED, AS LEAD FAILURE WAS SUSPECTED. THE RV LEAD IS A NON-BOSTON SCIENTIFIC DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PACEMAKER REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2496070 | INGENIO | PACEMAKER | LWW | BOSTON SCIENTIFIC CORPORATION | J172 | 294782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Female |