MAUDE Adverse Event Report: MPRI CAPSURE EPICARDIAL LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)

Model Number	4965-35
Medical Device Problem Codes	Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	03/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced chest pain.It was reported that the right atrial (ra) lead exhibited possible oversensing and loss of capture along with far field r-wave (ffrw) oversensing on stored electrograms (egm) resulting in false termination of atrial tachycardia/atrial fibrillation (at/af) episodes and inappropriate pacing.The lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 4965-35 lead was implanted on (b)(6) 2017.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
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 chest pain was not related to the ra lead.

• Brand Name: CAPSURE EPICARDIAL LEAD
• Common Device Name: DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18940480
• Report Number: 2649622-2024-07661
• Device Sequence Number: 12452697
• Product Code: NVN
• UDI-Device Identifier: 00613994501776
• UDI-Public: 00613994501776
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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
• Report Date (Section B): 04/18/2024

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: 06/20/2019
• Device Model Number: 4965-35
• Device Catalogue Number: 4965-35
• 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: 03/09/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/18/2024
• Date Device Manufactured: 08/08/2017
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 36 KG