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

Model Number 694765

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

Patient Problems Distress (2329); Shock from Patient Lead(s) (3162)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported by the patient that the device was defective and had been inactivated but could not be replaced due to potential bleeding problems.It was determined that the patient had been inappropriately shocked due to noise on the right ventricular (rv) lead and has since suffered post-traumatic stress.The patient's system was inactivated.The decision was made to not replace the lead as the patient's ejection fraction had improved.The lead remains in situ. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical product: biotronik crt-d, implant date: unknown.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the rv lead also had elevated impedance and there was a concern for a fracture.

• Brand Name: SPRINT QUATTRO SECURE 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: 13978837
• MDR Text Key: 288472956
• Report Number: 2649622-2022-06191
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00613994249890
• UDI-Public: 00613994249890
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

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: 03/18/2010
• Device Model Number: 694765
• Device Catalogue Number: 694765
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 05/31/2023
• Date Device Manufactured: 03/28/2008
• 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: 419588 LEAD, 5568-45 LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female