MAUDE Adverse Event Report: MPRI CAPSURE Z NOVUS LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number	5054-58
Medical Device Problem Codes	Fracture (1260); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately five and a half years post right ventricular (rv) lead implantation, the lead fractured and was replaced with another rv lead.It was further reported that approximately fifteen years later, the replacement rv lead had a suspected fracture in the voltage portion and exhibited out of range (oor) high pacing impedance and high thresholds.The two leads were partially clipped and capped.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: ddmb1d1 icd, implanted: (b)(6) 2017; 407645 lead, implanted: (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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CAPSURE Z NOVUS LEAD
• 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: 21344139
• Report Number: 2649622-2025-03847
• Device Sequence Number: 9079311
• Product Code: DTB
• UDI-Device Identifier: 00681490123228
• UDI-Public: 00681490123228
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P850089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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: 08/26/2011
• Device Model Number: 5054-58
• Device Catalogue Number: 5054-58
• 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: 02/03/2025
• Initial Report FDA Received Date: 02/10/2025
• Date Device Manufactured: 09/04/2009
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 694965 LEAD
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male