MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SPRINT QUATTRO LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	6944-65
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Over-Sensing (1438); Impedance Problem (2950); Unstable Impedance (4085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: dtpa2d1 crtd implanted: (b)(6) 2025, evolutfx-23 heart valve implanted: (b)(6) 2024, 457453 lead implanted: (b)(6) 2017, 419488 lead implanted: (b)(6) 2017.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 reported that the right ventricular (rv) lead had a suspected coil fracture.It was further reported that the lead triggered an alert for high out of range (oor) pacing impedance, high out of range (oor) defibrillation impedance, undefined high out of range (oor) superior vena cava (svc) coil defibrillation impedance, as well as exhibiting varying rv defibrillation impedance, varying svc defibrillation impedance, and varying pacing impedance.Right ventricular (rv) lead defibrillation impedance also exhibited a rising trend.It was further reported that there was oversensing present on the current electrograms (egm).The lead was capped and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Corrected: h2.3, h2.6 annex b, h2.6 annex c, h2.6 annex d 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 of the superior vena cava defibrillation coil was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was rising.Analysis of the device memory indicated the impedance trend of the right ventricular defibrillation coil was variable.Analysis of the device memory indicated the impedance trend of the superior vena cava defibrillation coil was variable.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was variable.Analysis of the device memory observed noise on the electrogram waveforms.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: SPRINT QUATTRO LEAD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 24545638
• Report Number: 2649622-2026-06629
• Device Sequence Number: 13079389
• Product Code: LWS
• UDI-Device Identifier: 00643169451469
• UDI-Public: (01)00643169451469(17)180728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2018
• Device Model Number: 6944-65
• Device Catalogue Number: 6944-65
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 03/10/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/09/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2016
• 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: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG