MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA CAPSURE Z NOVUS LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	5054-52
Medical Device Problem Codes	Pacing Problem (1439); Extracardiac stimulation (1463); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced discomfort and pocket stimulation.It was reported that the right ventricular (rv) lead exhibited varying impedances, a large drop in impedance and high thresholds.An increase in rv pacing and high outputs was also observed.The rv lead and implantable pulse generator (ipg) remain in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 5076-45 lead implanted on (b)(6) 2004.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
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was variable.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was decreasing.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.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 there was no performance issue with the ipg.The rv lead outputs were reprogrammed.It was also noted that the impedance had stabilized.

• Brand Name: CAPSURE Z NOVUS 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 55112-4391 ; 7635269277
• MDR Report Key: 22434446
• Report Number: 2649622-2025-18291
• Device Sequence Number: 11920130
• Product Code: DTB
• UDI-Device Identifier: 00681490123167
• UDI-Public: (01)00681490123167(17)060609
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P850089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 06/09/2006
• Device Model Number: 5054-52
• Device Catalogue Number: 5054-52
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2004
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 72 KG