MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	694765
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right ventricular (rv) lead appears to potentially have a suspected rv tip electrode fracture.It was noted that the rv lead triggered a bipolar and tip to coil impedance warning due to high and undefined impedance measurement.The lead was explanted and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 429688 lead; 694765 lead implanted: (b)(6) 2017; dtma1d1 crtd implanted: (b)(6) 2021.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
Correction: e1 product event summary: the distal portion of the lead was returned and analyzed.The analysis indicated that the lv1/distal conductor was fractured in-vivo in the anchoring sleeve area.Performance data collected from the device was received and analyzed.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 criteria for the right ventricular lead integrity alert were met.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was variable.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.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 SECURE MRI SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 22205545
• Report Number: 2649622-2025-16147
• Device Sequence Number: 6755871
• Product Code: LWS
• UDI-Device Identifier: 00643169692381
• UDI-Public: (01)00643169692381(17)211028(21)TDG662368V
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 10/28/2021
• Device Model Number: 694765
• Device Catalogue Number: 694765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2019
• 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: 2088TC52 LEAD, 2088TC46 LEAD.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male