MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI QUAD CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number DTMB1Q1

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

Patient Problems Chest Pain (1776); Cardiac Enzyme Elevation (1838); Inflammation (1932); Pleural Effusion (2010); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 03/29/2017

Event Type  Injury  

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.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.

Event Description

It was reported that after implant of the cardiac resynchronization therapy defibrillator (crt-d) system, the patient presented with chest discomfort and mild troponin elevation.A chest x-ray revealed a pericardial effusion.A transthoracic echocardiogram revealed a pleural effusion, pericarditis and tamponade.The patient was treated with colchicine and discharged.The crt-d system remains in use.The patient is a participant in the adaptresponse clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: AMPLIA MRI QUAD CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6624229
• MDR Text Key: 77215182
• Report Number: 3004209178-2017-11957
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00643169705784
• UDI-Public: 00643169705784
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2018
• Device Model Number: DTMB1Q1
• Device Catalogue Number: DTMB1Q1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 06/29/2017; 06/29/2017
• Supplement Dates FDA Received: 08/09/2017; 10/03/2017
• Date Device Manufactured: 12/20/2016
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 82