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

Model Number DTMB2QQ

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Invalid Sensing (2293)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 07/29/2017

Event Type  malfunction  

Manufacturer Narrative

This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that 12 days after the implant procedure the patient experienced inappropriate shocks due to the device detecting rapidly conducting atrial fibrillation (af with rapid ventricular conduction.) therapies were disabled and the patient underwent atrioventricular (av) node ablation.The device remains in use.The patient is a participant in the world-wide randomized antibiotic envelope infection prevention trial clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: AMPLIA MRI QUAD CRT-D
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7417178
• MDR Text Key: 105288212
• Report Number: 9614453-2018-01068
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2018
• Device Model Number: DTMB2QQ
• Device Catalogue Number: DTMB2QQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2018
• Date Device Manufactured: 03/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0962-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 96