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

Model Number 6947M62

Device Problems Over-Sensing (1438); Decreased Sensitivity (2534)

Patient Problem Bradycardia (1751)

Event Date 02/21/2024

Event Type  Injury  

Event Description

It was reported that the right ventricular (rv) lead displayed intermittent oversensing, double counting beats, and a slight decrease in r-waves.The patient presented to the emergency department (ed) due to ¿bradying down.¿ additionally, the rv lead triggered lead integrity alerts (lias) for sensing integrity counter (sic) and high rate non-sustained (hrns) episodes.It was noted that the hrns showed intermittent physiologic oversensing due to combination of small/varying r waves, and r wave morphology.The lead remains in use.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 reported that the right ventricular (rv) lead displayed intermittent oversensing, double counting beats, and a slight decrease in r-waves.The patient presented to the emergency department (ed) due to appropriate device shocks and ¿bradying down.¿ additionally, the rv lead triggered lead integrity alerts (lias) for sensing integrity counter (sic) and high rate non-sustained (hrns) episodes.It was noted that the hrns showed intermittent physiologic oversensing due to combination of small/varying r waves, and r wave morphology.The lead remains in use.No further patient complications have been reported as a result of this event.It was further reported that the rv lead displayed t-wave oversensing (twos).

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: 19009348
• MDR Text Key: 338979633
• Report Number: 2649622-2024-08747
• 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: 03/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6947M62
• Device Catalogue Number: 6947M62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Date Device Manufactured: 07/13/2023
• 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: DVPA2D4 ICD
• Patient Outcome(s): Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 97 KG