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

Model Number	6947M62
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	06/15/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient with a single-chamber implantable cardioverter defibrillator (icd) is deceased following cardiac arrest where an episode of ventricular fibrillation (vf) was not successfully terminated.Review of the episode and therapy data indicated six high-voltage defibrillation shocks were attempted to be delivered, however short circuit protection (scp) was triggered during the first phase of high-voltage therapy delivery for all six shocks.The scp events resulted in less than the programmed high-voltage energy or no high-voltage energy being delivered which failed to terminate the rhythm.Review of historical device data showed no evidence on lead trends suggestive of a right ventricular (rv) lead issue that would have caused the scp events.Based on the available data, it was not possible to determine which part of the icd system triggered scp during high-voltage therapy delivery.
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 that the ventricular tachyarrhythmia therapy energy was low.A medical safety assessment was performed for this event.In summary, it is not possible to dissociate the observed device behavior from the patient¿s death.Electrograms show a v-sensed rhythm at 360 ms (166 bpm) with a premature ventricular contraction (pvc)-induced ventricular arrhythmia at 352 bpm.Six 0.0-0.3 joule (j) shocks were delivered that did not terminate the arrhythmia.The arrhythmia continued for 8 minutes and degraded into a fine vf, then the presenting rhythm showed no cardiac activity and was inconsistent with life.While it is possible the outcome would have been fatal even if six full energy shocks had been delivered, the six 0.0-0.3 j shocks delivered were less than the programmed energy voltage and did not terminate the ventricular arrhythmia.It was determined that the most likely cause of the event is related to a lead integrity issue, or related to the icd and unrelated to the lead.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: 25751974
• Report Number: 2649622-2026-20295
• Device Sequence Number: 21353899
• Product Code: NVY
• UDI-Device Identifier: 00643169082267
• UDI-Public: (01)00643169082267(17)150614
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 07/08/2026

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: 06/14/2015
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• 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: 06/15/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2013
• 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: DVBC3D4 ICD.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR
• Patient Sex: Male