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

The patient was part of sjm quadra assura cd3265 advisory alert.The 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: 6228781
• MDR Text Key: 64056189
• Report Number: 6228781
• 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

• Date FDA Received: 01/06/2017
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR