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

Model Number DTMA1QQ

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Ventricular Tachycardia (2132)

Event Date 12/26/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 1456q-86 lead implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that shortly after the implant of a cardiac resynchronization therapy defibrillator (crt-d) and a competitor lead, t he patient coded due to ventricular tachycardia (vt).Chest compression were delivered, and then patient was shocked with the programmer connected to the crt-d and with an external defibrillator.The patient was stabilized and was being transported back to their room.During the transport process, the patient coded again with several runs of vt.Shocks were attempted externally and with the implanted crt-d, but the shocks did not successfully treat the vt.Chest compression and other life saving strategies were attempted to no avail and the patient passed away.

Manufacturer Narrative

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

Event Description

It was further reported by the physician that the patient had pulmonary 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 was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CLARIA 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 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9603499
• MDR Text Key: 175453244
• Report Number: 9614453-2020-00185
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00763000059514
• UDI-Public: 00763000059514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/28/2021
• Device Model Number: DTMA1QQ
• Device Catalogue Number: DTMA1QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2019
• 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: 6935M55 LEAD, 5076-45 LEAD
• Patient Outcome(s): Death
• Patient Age: 77 YR