MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA CAPSURE SP NOVUS LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	559445
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Under-Sensing (1661)
Health Effect - Clinical Codes	Chest Pain (1776); Dizziness (2194); Presyncope (4410)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: 5054-52 implant date (b)(6) 2012.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.
Event or Problem Description
It was reported that the patient experienced near syncope/dizziness.Furthermore, the right ventricular (rv) lead exhibited short v-v intervals, oversensing, intermittent undersensing and low r-waves.It was also reported that the right atrial (ra) lead failed the atrial lead position check (alpc).Both the leads remain in use. no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was further reported that the rv lead continued to exhibit intermittent ventricular oversensing noted on recorded atrial tachycar dia/atrial fibrillation (at/af) episodes and short v-v intervals.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was further reported that ra lead exhibited potential atrial under sensing triggering device classified false termination of at/af event(s) at times.
Event or Problem Description
It was further reported that the patient experienced chest pain.It was further reported that the rv lead continued to exhibit short v-v intervals, oversensing and undersensing on stored electrograms (egm).The ra lead continued to exhibit undersensing on stored egms.
Additional Manufacturer Narrative
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: CAPSURE SP NOVUS LEAD
• 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 55112-4391 ; 7635269277
• MDR Report Key: 21273477
• Report Number: 2649622-2025-03074
• Device Sequence Number: 14405365
• Product Code: DTB
• UDI-Device Identifier: 00613994250230
• UDI-Public: (01)00613994250230(17)131221(21)LFD050095V
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P850089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/28/2025

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: 12/21/2013
• Device Model Number: 559445
• Device Catalogue Number: 559445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 05/31/2025; 07/09/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 05/26/2025; 06/16/2025; 07/28/2025
• Date Device Manufactured: 01/31/2012
• 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: W1DR01 IPG
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 113 KG