MAUDE Adverse Event Report: Medtronic Inc CapSure Epicardial Lead; PERMANENT PACEMAKER ELECTRODE

Model Number	4968-35
Medical Device Problem Codes	Fracture (1260); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead was fractured and exhibited an out of range (oor) impedance spike.The rv lead was capped and replaced. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 4968-60 lead implanted on(b)(6)2011. 383059 lead implanted on (b)(6)2010.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 Epicardial Lead
• Common Device Name: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): Medtronic Inc; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer (Section G): Medtronic Inc; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50189907
• Report Number: 2182208-2026-48077
• Device Sequence Number: 17666963
• Product Code: DTB
• UDI-Device Identifier: 00681490116725
• UDI-Public: (01)00681490116725(17)120928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P950024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 08/17/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2012
• Device Model Number: 4968-35
• Device Catalogue Number: 4968-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2010
• 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: W1TR03 CRT-P
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Weight: 119 LB