MAUDE Adverse Event Report: MPRI ATTAIN PERFORMA; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 459888

Device Problem Difficult To Position (1467)

Patient Problem Cardiac Perforation (2513)

Event Date 02/20/2015

Event Type  Injury  

Event Description

It was reported that the patient experienced a coronary sinus dissection during catheterism at the implant procedure.The left ventricular (lv) lead was not implanted and will be replaced at a later date.The patient is a participant in the (b)(6) study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

• Brand Name: ATTAIN PERFORMA
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• 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: 4677871
• MDR Text Key: 5687595
• Report Number: 2649622-2015-03965
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P080006
• 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: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2017
• Device Model Number: 459888
• Device Catalogue Number: 459888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• Date Device Manufactured: 02/06/2015
• 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; Required Intervention
• Patient Age: 00059 YR
• Patient Weight: 113