MAUDE Adverse Event Report: ST. JUDE MEDICAL, IMPLANTABLE ELECTRONIC SYSTEMS DIVISION UNIFY; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATI

Model Number CD3265-40

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

Patient Problem Complete Heart Block (2627)

Event Date 11/15/2016

Event Type  malfunction  

Event Description

Patient/device was part of sjm quadra assura cd3265-40 advisory alert.Patient has an underlying rhythm of chb.Decision was made to prophylactically change out device as the recommendation is if the device triggers alert, generator should be immediate = within 24 hours.

• Brand Name: UNIFY
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATI
• Manufacturer (Section D): ST. JUDE MEDICAL, IMPLANTABLE ELECTRONIC SYSTEMS DIVISION; 645 almanor ave.; sunnyvale CA 94085
• MDR Report Key: 6228785
• MDR Text Key: 64056096
• Report Number: 6228785
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/28/2016,12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CD3265-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2016
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 11/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR