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

Model Number	6944-58
Medical Device Problem Codes	Over-Sensing (1438); Decreased Sensitivity (2534)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead exhibited crosstalk and small r-waves.An attempt was made to lower output on the atrial lead to 1.0v (threshold is 0.75v) to omit crosstalk but it was still present.In addition to the crosstalk, bipolar sensing was 0.8mv and integrated bipolar was 3.5mv on the rv lead chronically.The decision was made to implant a new rv defibrillation lead.During the revision procedure; several locations were mapped in the ventricle but got poor r waves.R waves started in 7's and after tying down the lead had diminished to 1.75-3.125mv.R waves were felt to be inadequate.The decision was made to not implant a new rv defibrillation lead; rather add an rv pace/sense lead.The rv pace/sense lead was placed in the mid-high septum (a location that was unable to be used with the attempted rv defibrillation lead due to limited space and interaction with the chronic rv lead)with great sensing.The rv defibrillation coil impedances were stable and connected the existing rv defibrillation coils to the new implantable cardioverter defibrillator (icd) while using the rv pace/sense lead as well.The procedure was successfully completed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 5554-45 lead implanted: (b)(6) 2008 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: 23750695
• Report Number: 2649622-2025-34178
• Device Sequence Number: 15848856
• Product Code: LWS
• UDI-Device Identifier: 00613994249951
• UDI-Public: (01)00613994249951(17)100626
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 12/08/2025

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: 06/26/2010
• Device Model Number: 6944-58
• Device Catalogue Number: 6944-58
• 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: 11/20/2025
• Initial Report FDA Received Date: 12/08/2025
• Date Device Manufactured: 08/26/2008
• 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: DDBC3D1 ICD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male