INGEVITY+
Report
- Report Number
- 2124215-2024-81029
- Event Type
- Malfunction
- Date Received
- December 20, 2024
- Date of Event
- November 25, 2024
- Report Date
- November 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526604546
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS. 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. VISUAL INSPECTION NOTED THE HELIX MECHANISM WAS IN AN EXTENDED POSITION, WITH DRIED BLOOD AND TISSUE IN THE HELIX HOUSING. ADDITIONALLY, THE HELIX WAS NOTED TO BE BENT. A STYLET WAS INSERTED INTO THE LEAD LUMEN WITH NO RESISTANCE. A LABORATORY TECHNICIAN TESTED THE HELIX MECHANISM AND FOUND IT WAS NONFUNCTIONAL, CONFIRMING THE CLINICAL OBSERVATION OF HELIX EXTENSION/RETRACTION DIFFICULTIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH PACING THRESHOLDS AND VARIABLE IMPEDANCE MEASUREMENTS THAT WERE OBSERVED DURING THE IMPLANT PROCEDURE.
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED TO BE POSITIONED FOR LEFT BUNDLE BRANCH AREA PACING (LBBAP). HIGH PACING THRESHOLDS AND VARIABLE IMPEDANCE MEASUREMENTS BETWEEN 380-1800 OHMS WERE OBSERVED. DURING MULTIPLE POSITIONING ATTEMPTS, THE HELIX STOPPED FUNCTIONING AND COULD NOT BE RETRACTED. A NEW LEAD WAS PROVIDED TO THE PHYSICIAN AND WAS SUCCESSFULLY IMPLANTED IN THE LEFT BUNDLE BRANCH (LBB) AREA. IT WAS SUSPECTED THAT THE POOR THRESHOLD AND IMPEDANCE PARAMETERS OF THE FIRST LEAD WERE DUE TO SCAR TISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ATTEMPTED LEAD WAS EXPECTED TO BE RETURNED FOR ANALYSIS. PRODUCT RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED TO BE POSITIONED FOR LEFT BUNDLE BRANCH AREA PACING (LBBAP). HIGH PACING THRESHOLDS AND VARIABLE IMPEDANCE MEASUREMENTS BETWEEN 380-1800 OHMS WERE OBSERVED. DURING MULTIPLE POSITIONING ATTEMPTS, THE HELIX STOPPED FUNCTIONING AND COULD NOT BE RETRACTED. A NEW LEAD WAS PROVIDED TO THE PHYSICIAN AND WAS SUCCESSFULLY IMPLANTED IN THE LEFT BUNDLE BRANCH (LBB) AREA. IT WAS SUSPECTED THAT THE POOR THRESHOLD AND IMPEDANCE PARAMETERS OF THE FIRST LEAD WERE DUE TO SCAR TISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ATTEMPTED LEAD WAS EXPECTED TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2169921 | INGEVITY+ | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | NVN | BOSTON SCIENTIFIC CORPORATION | 7842 | 1352161 | 00802526604546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male |