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

Model Number DTMA2QQ

Device Problem Insufficient Information (3190)

Patient Problems Cardiopulmonary Arrest (1765); Neurological Deficit/Dysfunction (1982)

Event Date 07/17/2020

Event Type  malfunction  

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

Event Description

It was reported that the patient experienced a cardio-respiratory arrest and the exact cause is unable to be determined.It was noted that the patient wife found the patient at home unconscious in the morning.The patient wife called emergency services, which was a 15 to 20 minutes wait.It was noted that the patient was resuscitated by many external electric shocks.It was also noted that the patient neurological functions were damaged after a long time of no cardiac activity.The cardiac resynchronization therapy defibrillator (crt-d) remains in use.No further patient complications have been reported as a result of this event.

• 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: 10383126
• MDR Text Key: 202168050
• Report Number: 9614453-2020-02432
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2021
• Device Model Number: DTMA2QQ
• Device Catalogue Number: DTMA2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2019
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 80 YR