MAUDE Adverse Event Report: ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40

Device Problem Difficult to Interrogate (1331)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2012

Event Type  malfunction  

Event Description

It was reported that a field engineer had difficulty interrogating a device after implant.The device was successfully interrogated after the programmer was rebooted.

Manufacturer Narrative

All info 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 only represents an enhancement to the reporting criteria going forward.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D; 15900 valley view ct; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4054962
• MDR Text Key: 4909474
• Report Number: 2938836-2014-05990
• 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: 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: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2011
• Device Model Number: CD3231-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/27/2012
• Device Age: 28 MO
• Event Location: Other
• Date Manufacturer Received: 08/27/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2010
• 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
• Patient Age: 72 YR