FDA Adverse Event Malfunction Summary report: N

CAPSUREFIX NOVUS LEAD MRI SURESCAN

MDR report key: 21636066 · Received March 18, 2025

Report

Report Number: 2649622-2025-07597
Event Type: Malfunction
Date Received: March 18, 2025
Date of Event: March 5, 2025
Report Date: March 18, 2025
Manufacturer: MPRI
Product Code: DTB
UDI-DI: 00643169633759
PMA / PMN Number: P930039
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D10: 0155 LEAD IMPLANTED (B)(6) 2003 0155 ENDOTAK LEAD IMPLANTED 09-JAN-2003 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1212673	CAPSUREFIX NOVUS LEAD MRI SURESCAN	PERMANENT PACEMAKER ELECTRODE	DTB	MPRI	5076-52		00643169633759

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR	Male		5867-3M ADAPTOR, DDPA2D1 ICD,