MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba CapSure Epicardial Lead; PERMANENT PACEMAKER ELECTRODE

Model Number	4968-60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pain (1994); Dizziness (2194); Obstruction/Occlusion (2422); Ambulation or Postural Difficulties (2544); Peripheral Edema (4578)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that they experienced ongoing concerns related to cardiac resynchronization therapy defibrillator (crt-d) follow-up and cardiac evaluation.The patient reported shortness of breath, dizziness, left-sided pain, leg edema, and difficulty walking, and stated that they had been told they had an obstruction and needed additional workup, including blood testing and an echocardiogram with contrast.The patient also reported that their carelink monitor was not online and that there were delays and difficulties with follow-up care and referral coordination.The patient expressed frustration that the recommended evaluation and testing had not yet been completed.The crt-d system remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtma1d4 crt-d implanted (b)(6) 2022.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 Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): Medtronic Puerto Rico Villalba; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50195224
• Report Number: 2649622-2026-23460
• Device Sequence Number: 9887287
• Product Code: DTB
• UDI-Device Identifier: 00613994492340
• UDI-Public: (01)00613994492340(17)181213
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 12/13/2018
• Device Model Number: 4968-60
• Device Catalogue Number: 4968-60
• 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: 07/21/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 01/26/2017
• 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: 6947M55 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male