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

Model Number 6947M62

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Chest Pain (1776); Shock from Patient Lead(s) (3162)

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: 5076-45 lead implanted: (b)(6) 2011.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 the right ventricular (rv) lead is possibly fractured and caused inappropriate delivery of shocks to the patient due to noise.It was noted that the lead triggered a lead integrity alert (lia). the patient was hospitalized. the lead was inactivated and remains implanted in the patient.No further patient complications have been reported as a result of this event.

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 further reported that the lia was triggered by high rate non-sustained episodes and sensing integrity counter (sic).

Event Description

It was further reported that the patient had complained of the device misfiring and chest pain at rest.The rv lead had triggered impedance warnings for out of range (oor) high pacing impedance.There were elevated sensing integrity counter (sic) and the rv lead was oversensing on presenting electrograms (egm).

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.

• 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: 19091233
• MDR Text Key: 339982381
• Report Number: 2649622-2024-10081
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2015
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/02/2024
• Supplement Dates FDA Received: 04/12/2024; 04/25/2024
• Date Device Manufactured: 08/27/2013
• 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: DDMC3D4 ICD
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female