CAPSUREFIX NOVUS LEAD MRI SURESCAN
Report
- Report Number
- 3008973940-2025-08457
- Event Type
- Injury
- Date Received
- November 6, 2025
- Date of Event
- October 18, 2025
- Report Date
- November 25, 2025
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- DTB
- UDI-DI
- 00681490124799
- PMA / PMN Number
- P930039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION: B5. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CONTINUATION OF D10: D314TRG CRT-D, IMPLANTED: (B)(6) 2012; 357-40C CRT-D, IMPLANTED: (B)(6) 2015; 694965 LEAD IMPLANTED: (B)(6) 2007, MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT DURING A GENERATOR CHANGE OUT PROCEDURE IT WAS NOTED THAT WHEN THE LEFT VENTRICULAR (LV) LEAD WAS ATTACHED TO THE NEW GENERATOR FREQUENT OVERSENSING WAS NOTED ON THE LEAD. THE LV LEAD WAS REATTACHED WITH THE SAME RESULT. ADDITIONALLY, THE LV LEAD EXHIBITED HIGH PACING IMPEDANCE, NO CAPTURE AND CONFIRMED LOW VOLTAGE FRACTURE. THE LV LEAD WAS CAPPED, INACTIVATED AND REMAINS IN THE PATIENT. IT WAS ALSO REPORTED WHEN THE RIGHT ATRIAL (RA) LEAD WAS ATTACHED TO THE NEW GENERATOR AND THERE WAS NO CAPTURE. THE RA LEAD WAS ALSO NOTED TO EXHIBIT HIGH THRESHOLDS. THE RA LEAD REMAINS IMPLANTED, IN-SERVICE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE, NO CAPTURE AND SUSPECTED LOW VOLTAGE FRACTURE. THE RV LEAD WAS CAPPED, INACTIVATED AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT DURING A GENERATOR CHANGE OUT PROCEDURE IT WAS NOTED THAT WHEN THE LEFT VENTRICULAR (LV) LEAD WAS ATTACHED TO THE NEW GENERATOR FREQUENT OVERSENSING WAS NOTED ON THE LEAD. THE LV LEAD WAS REATTACHED WITH THE SAME RESULT. ADDITIONALLY, THE LV LEAD EXHIBITED HIGH PACING IMPEDANCE, NO CAPTURE AND CONFIRMED LOW VOLTAGE FRACTURE. THE LV LEAD WAS CAPPED, INACTIVATED AND REMAINS IN THE PATIENT. IT WAS ALSO REPORTED WHEN THE RIGHT ATRIAL (RA) LEAD WAS ATTACHED TO THE NEW GENERATOR AND THERE WAS NO CAPTURE. THE RA LEAD WAS ALSO NOTED TO EXHIBIT HIGH THRESHOLDS. THE RA LEAD REMAINS IMPLANTED, IN-SERVICE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE, NO CAPTURE AND SUSPECTED LOW VOLTAGE FRACTURE. THE RV LEAD WAS CAPPED, INACTIVATED AND REMAINS IN THE PATIENT.
IT WAS FURTHER REPORTED THAT THE RV, RA AND LV LEADS WERE FULLY EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1701615 | CAPSUREFIX NOVUS LEAD MRI SURESCAN | PERMANENT PACEMAKER ELECTRODE | DTB | MEDTRONIC SINGAPORE OPERATIONS | 5076-45 | 00681490124799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male | Required Intervention| H | 419378 LEAD |