MAUDE Adverse Event Report: ST. JUDE MEDICAL INC., CRMD UNIFY CRT-D, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK

Model Number CD3231-40Q

Device Problem Pacing Problem (1439)

Patient Problems Dizziness (2194); Loss of consciousness (2418)

Event Date 04/25/2012

Event Type  malfunction  

Event Description

It was reported that a patient in the hospital for non cardiac reasons was being monitored on a surface electrocardiogram.Twice the monitor showed episodes of p waves without corresponding ventricular pacing, allowing the ventricular rate to drop.The patient felt dizzy and briefly lost consciousness.No noise was found.The patient will be monitored.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report represents an enhancement to the reporting criteria going forward.

• Brand Name: UNIFY CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK
• Manufacturer (Section D): ST. JUDE MEDICAL INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4089428
• MDR Text Key: 4744474
• Report Number: 2938836-2014-05668
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/25/2012
• Device Age: 12 MO
• Event Location: Other
• Date Manufacturer Received: 04/25/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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 Age: 80 YR