INGEVITY+
Report
- Report Number
- 2124215-2024-65149
- Event Type
- Injury
- Date Received
- October 17, 2024
- Date of Event
- September 25, 2024
- Report Date
- February 20, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526604577
- PMA / PMN Number
- P150012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS RESULTING IN A LEAD SAFETY SWITCH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IMPEDANCE HAS BEEN IN THE 600-700 OHMS RANGE SINCE IMPLANT UNTIL THE GREATER THAN 3000 OHMS MEASUREMENT WAS GENERATED. REPROGRAMMING OPTIONS AND FURTHER EVALUATION WERE DISCUSSED BY TS. FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH CAPTURE THRESHOLDS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT IS EXPECTED TO RECEIVE THIS PRODUCT FOR ANALYSIS.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS RESULTING IN A LEAD SAFETY SWITCH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IMPEDANCE HAS BEEN IN THE 600-700 OHMS RANGE SINCE IMPLANT UNTIL THE GREATER THAN 3000 OHMS MEASUREMENT WAS GENERATED. REPROGRAMMING OPTIONS AND FURTHER EVALUATION WERE DISCUSSED BY TS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS RESULTING IN A LEAD SAFETY SWITCH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IMPEDANCE HAS BEEN IN THE 600-700 OHMS RANGE SINCE IMPLANT UNTIL THE GREATER THAN 3000 OHMS MEASUREMENT WAS GENERATED. REPROGRAMMING OPTIONS AND FURTHER EVALUATION WERE DISCUSSED BY TS. FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS RESULTING IN A LEAD SAFETY SWITCH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT IMPEDANCE HAS BEEN IN THE 600-700 OHMS RANGE SINCE IMPLANT UNTIL THE GREATER THAN 3000 OHMS MEASUREMENT WAS GENERATED. REPROGRAMMING OPTIONS AND FURTHER EVALUATION WERE DISCUSSED BY TS. FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO HIGH CAPTURE THRESHOLDS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1148954 | INGEVITY+ | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7841 | 1479125 | 00802526604577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention| H |