MAUDE Adverse Event Report: MPRI CAPSURE SENSE LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE

Model Number	407458
Medical Device Problem Codes	Intermittent Capture (1080); Capturing Problem (2891); Unstable Capture Threshold (3269)
Health Effect - Clinical Codes	Bradycardia (1751); Dizziness (2194); Syncope/Fainting (4411)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced syncope, bradycardia and dizziness.It was also reported that the right ventricular (rv) lead exhibited rising thresholds, unstable thresholds and intermittent capture.The rv lead was capped and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 305c229 tissue valve, implant date: (b)(6) 2013.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 SENSE LEAD MRI SURESCAN
• 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: 20491127
• Report Number: 2649622-2024-27966
• Device Sequence Number: 14332593
• Product Code: DTB
• UDI-Device Identifier: 00885074200668
• UDI-Public: 00885074200668
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P830061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 01/23/2015
• Device Model Number: 407458
• Device Catalogue Number: 407458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/21/2024
• Date Device Manufactured: 02/11/2013
• 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: ADDR01 IPG, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male