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

Model Number	6944-65
Medical Device Problem Codes	Failure to Capture (1081); Pacing Problem (1439); Under-Sensing (1661); Device Sensing Problem (2917); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued from d10: dtpa2q1 crt-d implanted: (b)(6) 2024 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 patient was checked at the hospital due to suspected loss of capture, inappropriate pacing, and delivered high voltage therapy.The right ventricular (rv) lead capture was unable to be confirmed.The rv lead exhibited intermittent undersensing prior to ventricular fibrillation (vf) detection and high thresholds.The rv lead remains in use.No patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the rv lead continued to exhibit intermittent undersensing triggered false termination arrhythmia in pr ogress in addition to fluctuating r-wave amplitude.
Additional Manufacturer Narrative
Correction: h6 device codes (fdd/annex a):a070910 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: 23501553
• Report Number: 2649622-2025-31392
• Device Sequence Number: 9038096
• Product Code: LWS
• UDI-Device Identifier: 00643169451469
• UDI-Public: (01)00643169451469(17)180728
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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
• Report Date (Section B): 04/23/2026

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: 10/18/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 04/23/2026
• 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: 5554 LEAD, 4598 LEAD
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 117 KG