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

Model Number	4592-53
Medical Device Problem Codes	Mechanical Problem (1384); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post implantable pulse generator (ipg) changeout the right atrial (ra) lead exhibited oversensing.The lead was reprogrammed.Approximately two weeks later, a shoulder rotation and a stress test on the pocket site were performed in order to check the lead condition again at the outpatient visit and further oversensing occurred.Also, no loose pin was observed in the photos when checking the a chest x-ray however, a loose pin could not be ruled out.The surgeon decided not to change the settings and continued to follow-up with the lead remaining 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.

• 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: 20650618
• Report Number: 2649622-2024-30167
• Device Sequence Number: 19623760
• Product Code: DTB
• UDI-Device Identifier: 00681490114974
• UDI-Public: 00681490114974
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/15/2007
• 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: 10/22/2024
• Initial Report FDA Received Date: 11/11/2024
• Date Device Manufactured: 08/09/2005
• 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: ATSR01 IPG.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown