MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN STABILITY QUAD MRI SURESCAN; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P

Model Number 479878

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271); Heart Block (4444)

Event Date 01/26/2022

Event Type  Death  

Manufacturer Narrative

Continuation of concomitant medical products: dvbb2d4 icd, implanted: (b)(6) 2014.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 reported that during a procedure to upgrade to a cardiac resynchronization therapy defibrillator (crt-d) system with an left ventricular (lv) lead, occlusion was observed in the left subclavian.Attempts were made to access but were unsuccessful.The procedure was changed to a right sided approach and there were ¿challenges¿ obtaining access to the coronary sinus.The physician was ultimately able to deploy the lead however the procedure was aborted due to hypotension and a pulseless electrical activity arrest.A code blue was called and cardiopulmonary resuscitation was performed but was unsuccessful and the patient was declared deceased at the end of the code.The immediate cause of death was noted as ¿likely multifactorial and related to¿ the patients ¿baseline severe left ventricular systolic dysfunction, recurrent ventricular arrhythmias, possibly a pericardial effusion although definitive evidence of tamponade could not be demonstrated and possibly an acute coronary event¿.The patient is a participant in a clinical study.

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.

• Brand Name: ATTAIN STABILITY QUAD MRI SURESCAN
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 16613594
• MDR Text Key: 312003662
• Report Number: 2182208-2023-00814
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 479878
• Device Catalogue Number: 479878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• 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: 6943-35 LEAD
• Patient Outcome(s): Death