MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SPRINT QUATTRO SECURE MRI SURESCAN; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	6947M55
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: dtma1d4 crtd, 429678 lead implanted: (b)(6) 2014, 5076-45 lead 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 right ventricular (rv) lead had a suspected fracture on the low voltage portion of the lead.It was further reported that multiple lead integrity alerts (lia) were triggered to due high rate non-sustained episodes and sensing integrity counter (sic).It was further reported that the lead exhibited noise, oversensing and t-wave oversensing (twos).The lead was reprogrammed and remains in use.The patient was placed on a life-vest.No patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the rv lead was explanted and replaced.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met.Analysis of the device memory indicated noise.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated t-wave oversensing.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product event summary: the full lead was returned in segments, analyzed.Analysis indicated the right ventricular defibrillation coil conductor was fractured in-vivo at the crimp of the cross-grove.The outer insulation of the lead was breached due to bi/multi-lumen tubing voids while in vivo.The outer insulation was ruptured.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: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 24393015
• Report Number: 2649622-2026-04950
• Device Sequence Number: 10490405
• Product Code: NVY
• UDI-Device Identifier: 00643169309715
• UDI-Public: (01)00643169309715(17)151220
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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: 12/20/2015
• Device Model Number: 6947M55
• Device Catalogue Number: 6947M55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 03/23/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/11/2026; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2014
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female