MAUDE Adverse Event Report: IPG MFG SWITZERLAND PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D354TRG

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

Patient Problem Pericardial Effusion (3271)

Event Date 06/05/2011

Event Type  Injury  

Event Description

It was reported that the postoperatively the patient complained of retrosternal pain.Diagnostics included chest x-ray, echocardiography, blood analysis, and electrocardiogram.The patient was hospitalized and diagnosed with pericardial effusion.The device remains in use.The patient is enrolled in the (b)(6).No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This model number is not approved for distribution in the u.S., however, it is similar to a device marketed in the u.S.The event occurred outside the us and is being reported due to an alleged malfunction.All information provided is included in this report.(b)(4).

• Brand Name: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4606460
• MDR Text Key: 5761090
• Report Number: 9614453-2015-00537
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2011
• Device Model Number: D354TRG
• Device Catalogue Number: D354TRG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2011
• Date Device Manufactured: 06/24/2010
• 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: 6944-65 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00051 YR