MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL AMPLIA MRI QUAD CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMB2QQ

Device Problems Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661); Device Sensing Problem (2917)

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130); Loss of consciousness (2418)

Event Date 06/27/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced arrhythmias of ventricular tachycardia (vt) and ventricular fibrillation (vf) and suffered cardiac arrest.It was alleged that the right ventricular (rv) lead had significant undersensing of very fine ventricular fibrillation (vf) episodes.The episodes went undetected resulting in no therapy to the patient during some episodes.Review of device data indicated lead integrity alert (lia) was triggered due to an on-going ventricular fibrillation (vf) storm.The cardiac resynchronization therapy defibrillator (crt-d) misclassified the events as non-sustained ventricular tachycardia rather than an ongoing vf rhythm due to the polymorphic nature of the rhythm.There was slight a delay of vf detection due to the polymorphic behavior.The delayed treatment followed by a series of shocks led to an ischemic event and loss of consciousness.The patient did not recover and died.The device system was inactivated and remains in the patient.

Event Description

It was additionally disclosed that the cause of death was recorded as cardiogenic shock secondary to cardiac arrest.

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the device failed to deliver a shock.Analysis of the device memory had an observation relating to vf detection.Analysis of the device memory indicated right ventricular undersensing.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: AMPLIA MRI QUAD CRT-D SURESCAN
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• MDR Report Key: 12101396
• MDR Text Key: 259463176
• Report Number: 9614453-2021-02696
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/14/2020
• Device Model Number: DTMB2QQ
• Device Catalogue Number: DTMB2QQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6935M62 LEAD, MDT-LEAD; 6935M62 LEAD, MDT-LEAD
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 69 YR