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

Model Number	693565
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194); Presyncope (4410)
Date of Event	03/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: ddbb1d1 icd, 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 patient had presented to the hospital with complaints of dizziness/near syncope and nausea.The right ventricular (rv) lead exhibited oversensing on stored episodes, high thresholds, and high, out-of-range, undefined pacing impedances.The threshold and pacing impedance values were known and the pacing impedance values were consistent with historical measurements.It was also reported that the rv lead had triggered a historical lead integrity alert (lia) due to high rate non-sustained episodes and the sensing integrity counter (sic) being incremented.There was also a historical rv lead impedance alert due to high, out-of-range, undefined pacing impedances.The lead remains in use.No patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that the patient had presented to the hospital with complaints of dizziness/near syncope and nausea.The right ventricular (rv) lead exhibited oversensing on stored episodes, high thresholds, and high, out-of-range, undefined pacing impedances.The threshold and pacing impedance values were known and the pacing impedance values were consistent with historical measurements.It was also reported that the rv lead had triggered a historical lead integrity alert (lia) due to high rate non-sustained episodes and the sensing integrity counter (sic) being incremented.There was also a historical rv lead impedance alert due to high, out-of-range, undefined pacing impedances.The lead remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Correction: b5 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: 25124933
• Report Number: 2649622-2026-13390
• Device Sequence Number: 12970172
• Product Code: LWS
• UDI-Device Identifier: 00613994446350
• UDI-Public: (01)00613994446350(17)120902
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 05/12/2026

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: 09/02/2012
• Device Model Number: 693565
• Device Catalogue Number: 693565
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 09/17/2010
• 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: 5076-52 LEAD.
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 111 KG