MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40Q

Device Problems Defibrillation/Stimulation Problem (1573); Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 06/01/2017

Event Type  Injury  

Event Description

It was reported that the patient coded in the hospital due to cardiac arrest.The patient required cpr and external shocks.The patient was unresponsive.The device did not detect arrhythmia and therefore did not intervene.Programming changes were suggested.No further information available.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6685135
• MDR Text Key: 79024695
• Report Number: 2938836-2017-29939
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2017

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: 08/31/2013
• Device Model Number: CD3249-40Q
• Device Catalogue Number: CD3249-40Q
• Device Lot Number: 3628878
• Other Device ID Number: 05414734504546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2017
• Initial Date FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR