MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE S MRI SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number 6935M62

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081)

Patient Problems Dyspnea (1816); Muscle Weakness (1967); Pneumonia (2011); Pulmonary Edema (2020); Renal Failure (2041); Tachycardia (2095); Dizziness (2194); Presyncope (4410)

Event Date 02/20/2024

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department with pulmonary edema and tachycardia.It was noted that the right ventricular (rv) lead had a potential for non-capture.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.

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 patient was hospitalized at the time of the event.It was noted that the rv lead was programmed subthreshold to avoid pacing, per the implanting provider.It was noted that the patient presented to the office previously with dizziness and lightheadedness and was placed on a diuretic.The patient later complained of weakness and near syncope, lab results suggested acute renal failure.She was discharged and later returned to the emergency department due to shortness of breath.An echocardiogram revealed diffuse b-lines throughout the right lung consistent with congestive heart failure exacerbation.The patient was intubated and treated for pneumonia and later underwent cardioversion.It was noted that there was noise on the rv lead that was not picked up by the device.The patient was discharged from the hospital for later follow-up.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• 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: 18947101
• MDR Text Key: 338184719
• Report Number: 2649622-2024-07729
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00643169356566
• UDI-Public: 00643169356566
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 04/18/2024

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: 12/03/2020
• 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: 02/24/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/18/2024
• Date Device Manufactured: 12/17/2018
• 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: DTMA1D4 CRTD, 383069 LEAD, 407645 LEAD
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 102 KG