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

Model Number CD3231-40Q

Device Problems Decreased Sensitivity (2534); High Capture Threshold (3266)

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

Event Date 08/22/2011

Event Type  Injury  

Event Description

It was reported that high ventricular capture threshold and a decrease in sensing r waves was observed.There were no signs of lead dislodgement.The system was explanted.

Manufacturer Narrative

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.Evaluation description: the reported event field of capture anomaly and sensing anomaly could not be reproduced in the laboratory.The device was tested on the bench and on automated test equipment and no.

• Brand Name: UNIFY CRT-D, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3876344
• MDR Text Key: 4593547
• Report Number: 2938836-2014-02942
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: CD3231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/19/2011
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/22/2011
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/24/2011
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 7120Q/59, BNP014115
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR