MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE MRI SURESCAN; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 6947M62

Device Problems High impedance (1291); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that an interrogation showed the implantable cardioverter defibrillator (icd) possibly inappropriately withheld therapies due to the device discriminator for episodes detected as supra ventricular tachycardia (svt) that the clinician suspected is a ventricular arrhythmia.The interrogation also showed previously alerts triggered by the right ventricular (rv) lead for high out of range (oor) superior vena cava (svc) defibrillation impedance, and a gradual rise in pacing impedance was observed on lead trends.The rv lead also had an observation for high thresholds, and lead trends showed an abrupt increase in threshold measurements.The icd and rv lead remain in use. no further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE MRI SURESCAN
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 18951892
• MDR Text Key: 338265039
• Report Number: 2649622-2024-07806
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 00643169356627
• UDI-Public: 00643169356627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2018
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Date Device Manufactured: 01/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DVFB1D4 ICD
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 99 KG