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

Model Number	6935M72
Medical Device Problem Codes	Signal Artifact/Noise (1036); Intermittent Capture (1080); Fracture (1260); High impedance (1291); Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) device delivered inappropriate therapies to the patient and the right atrial (ra) lead exhibited undersensing triggering device classified false termination of atrial tachycardia/atrial fibrillation (at/af) event(s) at times.It was further reported that the right ventricular (rv) lead triggered lead integrity alerts (lias) due to high rate-non-sustained episodes, oversensing, non-physiologic/sensing integrity counter (sic) with one thousand two hundred ninety-nine short v-v intervals, noise, undefined high pacing impedance, and undersensing saved on electrograms and in addition, appeared to result in intermittent capture due to a lead fracture.On the day of extraction, imaging and interrogation of the device were performed and inappropriate sensing in bipolar and integrated bipolar mode could be observed and with arm movement showed an increase of oversensing.The crt-d, ra lead, and rv lead were subsequently replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: 407652 implanted (b)(6) 2012; 511211 lead implanted(b)(6) 2018; 511211 lead implanted (b)(6) 2018; 5071-53 lead implanted (b)(6) 2017; 5071-53 lead implanted (b)(6) 2017; 401258 lead implanted (b)(6) 1984.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 S MRI SURESCAN
• 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: 23006906
• Report Number: 2649622-2025-24882
• Device Sequence Number: 10516670
• Product Code: LWS
• UDI-Device Identifier: 00643169309784
• UDI-Public: (01)00643169309784(17)170805
• 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
• Device Explanted Year: 2025
• 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): 09/09/2025

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: 08/05/2017
• Device Model Number: 6935M72
• Device Catalogue Number: 6935M72
• 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: 08/16/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 08/22/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DTMA1D4 CRT-D
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 75 KG