MAUDE Adverse Event Report: Medtronic Puerto Rico Villalba CapSureFix Novus Lead MRI SureScan; PERMANENT PACEMAKER ELECTRODE

Model Number	5076-45
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead triggered a lead integrity alert (lia) due to sensing integrity counter (sic) and high rate non-sustained episodes.In addition both the rv and right atrial (ra) lead exhibited noise and oversensing.The patient received an inappropriate shock due to the noise and oversensing.It was also noted that the patient was in a swimming pool at the time of the lia.The rv and ra leads remain in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: dtpa2qq crt-d implanted: (b)(6)2023 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: CapSureFix Novus Lead MRI SureScan
• 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: 50077689
• Report Number: 2649622-2026-22263
• Device Sequence Number: 21522703
• Product Code: DTB
• UDI-Device Identifier: 00643169448889
• UDI-Public: (01)00643169448889(17)170212
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 07/29/2026

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: 02/12/2017
• Device Model Number: 5076-45
• Device Catalogue Number: 5076-45
• 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: 07/12/2026
• Initial Report FDA Received Date: 07/29/2026
• Date Device Manufactured: 02/24/2015
• 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: 459878 LEAD, 6935M55 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 133 LB