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

Model Number 6935M62

Device Problem Failure to Capture (1081)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 03/22/2024

Event Type  Injury  

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 intra-operatively, the right ventricular (rv) lead implant was placed in the direction of the right ventricular apex, however, no capture was observed.The patient had a narrow right ventricular cavity, and several locations were attempted for placement and programming was done to optimize pacing for the patient.When the stylet was articulated for placement above septum, it was found out that the blood pressure could not be measured.When the cardiac shadow was checked with fluoroscopy, there was no heartbeat, a cardiac tamponade/blockage was determined, and drainage was performed.There was no noted resistance or stress felt during the placement attempt, and it was unknown where the cardiac tamponade/blockage occurred.Preparation was made for thoracotomy, but due to minimal bleeding, the patient was placed in the intensive care unit (icu) for observation.The lead was not used.No further patient complications have been reported as a result of this event.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19080193
• MDR Text Key: 339826939
• Report Number: 3008973940-2024-02576
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P920015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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: Health Professional
• Device Model Number: 6935M62
• Device Catalogue Number: 6935M62
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/10/2024
• Date Device Manufactured: 12/15/2023
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Female