MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6935M62

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Capturing Problem (2891); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problems Dyspnea (1816); Pain (1994)

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department with shortness of breath and left shoulder pain.A remote transmission showed that the right ventricular (rv) lead triggered alerts for undefined high pacing impedance with a noted impedance spike.The lead exhibited a gradual increase in thresholds that became high with no capture noted.In addition, oversensing was noted with pocket manipulation.Detections and rv lead impedance alerts were programmed off and the rv lead remains in use.No further patient complications have been reported as a result of this event.

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 the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance of the right ventricular pacing lead had a spike.Analysis of the device memory indicated pacing capture threshold in the right ventricle was rising.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 S MRI SURESCAN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 18990151
• MDR Text Key: 338772620
• Report Number: 2649622-2024-08517
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169356566
• UDI-Public: 00643169356566
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/09/2020
• Device Model Number: 6935M62
• Device Catalogue Number: 6935M62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2018
• 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: DTMB1QQ CRTD, 459888 LEAD, 5076-52 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 75 KG