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

Model Number CD3365-40Q

Device Problem Difficult to Interrogate (1331)

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

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was reported that the patient presented in the operating room for new system implant.Device was initially interrogated successfully, however, rf telemetry was intermittent and the programmer was not able to locate the device.Programmer was rebooted multiple times without resolving the issue.The device was not implanted.Patient condition post procedure was good.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.(b)(4).

Manufacturer Narrative

The reported rf telemetry anomaly was not confirmed in the laboratory.The device was tested on the bench and no anomaly was found.

• Brand Name: QUADRA ASSURA 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: sharon mathew ; 645 almanor avenue; sunnyvale, CA 94085 ; 4085226327
• MDR Report Key: 4670034
• MDR Text Key: 5728146
• Report Number: 2938836-2015-03365
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: CD3365-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• 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