INGEVITY
Report
- Report Number
- 2124215-2026-05619
- Event Type
- Malfunction
- Date Received
- January 30, 2026
- Date of Event
- January 27, 2026
- Report Date
- March 19, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NVN
- UDI-DI
- 00802526565519
- PMA / PMN Number
- P150012/S000
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT INVESTIGATION CONCLUSION CODE WAS SELECTED AVAILABLE INFORMATION INDICATED THAT THE SURGEON CONFIRMED THAT THEY BROKE THE LEAD WHEN HE OPENED THE POCKET. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF FRACTURE WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT.
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT THIS RIGHT VENTRICULAR (RV) LEAD DID NOT SHOW ANY PACING WITH A COMPETITOR PACING SYSTEM ANALYZER (PSA). IN ADDITION, THE PACE IMPEDANCE WERE HIGH AND OUT OF RANGE WITH THE NEW DEVICE. IT WAS NOTED THAT THE PHYSICIAN BROKE THE LEAD UPON OPENING THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS SURGICALLY ABANDONED.
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT THIS RIGHT VENTRICULAR (RV) LEAD DID NOT SHOW ANY PACING WITH A COMPETITOR PACING SYSTEM ANALYZER (PSA). IN ADDITION THE PACE IMPEDANCE MEASUREMENTS WERE HIGH AND OUT OF RANGE. IT WAS NOTED THAT THE PHYSICIAN BROKE THE LEAD UPON TAKING THE LEAD OUT OF THE PACKAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS SURGICALLY ABANDONED.
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT THIS RIGHT VENTRICULAR (RV) LEAD DID NOT SHOW ANY PACING WITH A COMPETITOR PACING SYSTEM ANALYZER (PSA). IN ADDITION, THE PACE IMPEDANCE WERE HIGH AND OUT OF RANGE WITH THE NEW DEVICE. IT WAS NOTED THAT THE PHYSICIAN BROKE THE LEAD UPON OPENING THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS SURGICALLY ABANDONED.
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT THIS RIGHT VENTRICULAR (RV) LEAD DID NOT SHOW ANY PACING WITH A COMPETITOR PACING SYSTEM ANALYZER (PSA). IN ADDITION, THE PACE IMPEDANCE WERE HIGH AND OUT OF RANGE WITH THE NEW DEVICE. IT WAS NOTED THAT THE PHYSICIAN BROKE THE LEAD UPON OPENING THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS SURGICALLY ABANDONED.
IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT THIS RIGHT VENTRICULAR (RV) LEAD DID NOT SHOW ANY PACING WITH A COMPETITOR PACING SYSTEM ANALYZER (PSA). IN ADDITION, THE PACE IMPEDANCE WERE HIGH AND OUT OF RANGE WITH THE NEW DEVICE. IT WAS NOTED THAT THE PHYSICIAN BROKE THE LEAD UPON OPENING THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS SURGICALLY ABANDONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 600004 | INGEVITY | DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES | NVN | BOSTON SCIENTIFIC CORPORATION | 7632 | 534786 | 00802526565519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |