MAUDE Adverse Event Report: ST. JUDE MEDICAL INC., CRMD ATLAS PLUS HF CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, NIK

Model Number V-341

Device Problems Over-Sensing (1438); Decreased Sensitivity (2534); Connection Problem (2900)

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

Event Date 09/09/2011

Event Type  Injury  

Event Description

It was reported that the physician observed a drop in the value of the ventricular sensing parameter and noise on the ventricular channel.The physician suspected a connection issue with the icd.The device was explanted.

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 only represents an enhancement to the reporting criteria going forward.Evaluation description included.The reported field event of decreased sensing amplitude was confirmed via review of the programmer printout.The reported field event of ventricular noise was confirmed via review of stored electrograms.The device was tested on the bench and using automated test equipment and no anomalies were observed.The cause of the decreased sensing amplitude could not be determined.The cause of the ventricular noise could not be determined.

• Brand Name: ATLAS PLUS HF CRT-D
• 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., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3879904
• MDR Text Key: 4589507
• Report Number: 2938836-2014-03479
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 05/31/2008
• Device Model Number: V-341
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2011
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/09/2011
• Device Age: 52 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/09/2011
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2007
• 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 Outcome(s): Required Intervention
• Patient Age: 70 YR