INGEVITY?+
Report
- Report Number
- 2124215-2025-73852
- Event Type
- Injury
- Date Received
- October 16, 2025
- Date of Event
- September 25, 2025
- Report Date
- January 23, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526604522
- PMA / PMN Number
- P150012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT. NO LEAD ISSUES WERE NOTED THAT WOULD HAVE MADE DISLODGEMENT MORE LIKELY THAN WHAT IS DESCRIBED IN THE INSTRUCTIONS FOR USE AS A KNOWN INHERENT RISK OF THE USE OF THIS PRODUCT. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THIS CORRECTION REPORT WAS SUBMITTED DUE TO CHANGES IN THE H3, DEVICE EVAL BY MANUFACTURER AND H6, EVALUATION CONCLUSION CODES FIELDS. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THIS LEFT BUNDLE BRANCH (LBB) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER LBB LEAD WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED APPROXIMATELY 20 MINUTES AFTER THE INITIAL IMPLANT PROCEDURE WAS COMPLETED THIS LBB LEAD DISLODGED. THE PATIENT WAS BROUGHT BACK IN AND ANOTHER LBB LEAD WAS IMPLANTED. THIS LBB HAS BEEN RETURNED AND ANALYSIS COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS LEFT BUNDLE BRANCH (LBB) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER LBB LEAD WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS LBB HAS BEEN RETURNED BUT ANALYSIS HAS NOT YET BEEN COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS LEFT BUNDLE BRANCH (LBB) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER LBB LEAD WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE PROVIDED APPROXIMATELY 20 MINUTES AFTER THE INITIAL IMPLANT PROCEDURE WAS COMPLETED THIS LBB LEAD DISLODGED. THE PATIENT WAS BROUGHT BACK IN AND ANOTHER LBB LEAD WAS IMPLANTED. THIS LBB HAS BEEN RETURNED BUT ANALYSIS HAS NOT YET BEEN COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS LEFT BUNDLE BRANCH (LBB) LEAD WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ANOMALY. ANOTHER LBB LEAD WAS IMPLANTED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS LBB HAS BEEN RETURNED BUT ANALYSIS HAS NOT YET BEEN COMPLETED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2535515 | INGEVITY?+ | IMPLANTABLE LEAD | NVN | BOSTON SCIENTIFIC CORPORATION | 7842 | 1520523 | 00802526604522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention| H |