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

Model Number CD3367-40Q

Device Problems Failure to Interrogate (1332); Premature End-of-Life Indicator (1480)

Patient Problem Dizziness (2194)

Event Date 10/29/2014

Event Type  Injury  

Event Description

It was reported that the patient presented with dizziness.The device could not be interrogated and had reached eol.The device was explanted and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Evaluation description: the reported field event of an inability to communicate with the device was confirmed in the laboratory and was due to low battery voltage.The low battery voltage was due to high current draw.The high current draw was caused by an anomalous component on the hybrid.

• Brand Name: QUADRA ASSURA DR 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: 4372260
• MDR Text Key: 5233718
• Report Number: 2938836-2014-19338
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: CD3367-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• 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