MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba CapSureFix Novus Lead MRI SureScan; PERMANENT PACEMAKER ELECTRODE

Model Number	5076-45
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d),  the ventricular tachycardia (vt) rhythm appears to fall in and out of detection possibly delaying therapy.  at device classified termination of events, arrhythmia appears to continue beneath detection rate.  the crt-d remains in use.  the right atrial (ra) lead, atrial lead position check failed due to an unknown/unspecified reason.It was further reported that another ra lead atrial lead position check failed and it was due to intermittent and sudden undersensing.The lead remains in use with the physician closely monitoring lead trends.No patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that during use of the cardiac resynchronization therapy defibrillator (crt-d),  the ventricular tachycardia (vt) rhythm appears to fall in and out of detection possibly delaying therapy.  at device classified termination of events, arrhythmia appears to continue beneath detection rate.  the crt-d remains in use.  the right atrial (ra) lead, atrial lead position check failed due to an unknown/unspecified reason.  it was further reported that the ra lead atrial lead position check failed due to intermittent and sudden undersensing.The lead remains in use with the physician closely monitoring lead trends.The patient is a participant in a clinical study.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: bis-is-15 adaptor and 6721m-50 defib epi patch implanted: (b)(6) 2021.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.
Additional Manufacturer Narrative
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.

• Brand Name: CapSureFix Novus Lead MRI SureScan
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50948182
• Report Number: 2649622-2026-28918
• Device Sequence Number: 18529771
• Product Code: DTB
• UDI-Device Identifier: 00643169633742
• UDI-Public: (01)00643169633742(17)221208
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/08/2022
• Device Model Number: 5076-45
• Device Catalogue Number: 5076-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/30/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DTPA2D1 CRTD, 5071-53 LEAD, 693558 LEAD
• Patient Age: 60 YR
• Patient Sex: Male