MAUDE Adverse Event Report: MPRI CAPSURE SP NOVUS LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	4592-53
Medical Device Problem Codes	Intermittent Capture (1080); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: 694765 lead implanted: (b)(6) 2009.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 right atrial (ra) lead displayed oversensing potentially impacting detection.Additionally, the right ventricular (rv) lead exhibited oversensing and sensing integrity counter (sic).According to a healthcare professional, the patient was undergoing a surgical procedure at the time of the episodes.Both leads remain in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5 and annex a codes added.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 right atrial (ra) lead displayed oversensing with possible false detection of atrial arrhythmia and unable to confirm consistent capture.The device appeared to be ¿pacing all over the place.¿ additionally, the right ventricular (rv) lead exhibited oversensing with possible inhibition of ventricular pacing.Sensing integrity counter (sic) was also observed.According to a healthcare professional, the patient was undergoing a surgical procedure at the time of the episodes.Follow up was conducted and indicated that rv noise was also observed.Both leads remain in use.No 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 via follow-up that the patient had been in an open heart coronary artery bypass graft (cabg) procedure.A temporary pacing device was placed following the procedure which was competing with the pacing of the icd system.

• Brand Name: CAPSURE SP NOVUS LEAD
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; 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: 21058912
• Report Number: 2649622-2025-00093
• Device Sequence Number: 8782702
• Product Code: DTB
• UDI-Device Identifier: 00885074200996
• UDI-Public: 00885074200996
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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
• Report Date (Section B): 01/23/2025

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: 04/16/2011
• Device Model Number: 4592-53
• Device Catalogue Number: 4592-53
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 01/07/2025; 01/14/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/15/2025; 01/23/2025
• Date Device Manufactured: 04/23/2009
• 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: DDBB1D1 ICD
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 99 KG