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

Model Number DTMC2QQ

Device Problem Pacing Problem (1439)

Patient Problems Arrhythmia (1721); Complete Heart Block (2627)

Event Date 10/22/2019

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 was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient experienced arrhythmia and heart block.The cardiac resynchronization therapy defibrillator (crt-d) was suspected of under pacing.The patient was observed on holter monitor with heart rates below the programmed lower pacing limit.However, threshold, sensing, and impedance tests appeared normal at follow up.Diagnostic testing/troubleshooting and reprogramming were performed.The device remains in use.It was also noted that the right ventricular (rv) lead exhibited suspected oversensing.The lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: COMPIA 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: 9324682
• MDR Text Key: 168280109
• Report Number: 9614453-2019-03863
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2019
• Device Model Number: DTMC2QQ
• Device Catalogue Number: DTMC2QQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2017
• 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: 5076-52 LEAD, 6935M55 LEAD, 429878 LEAD
• Patient Outcome(s): Required Intervention