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

Model Number CD3249-40Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problems Fainting (1847); Pain (1994); Ventricular Tachycardia (2132)

Event Date 02/21/2017

Event Type  malfunction  

Event Description

It was reported that the patient was having abdominal pain with pre syncopal.External defibrillation was used when the device did not convert the patient out of a ventricular tachycardia.The device was reprogrammed however it did not solve the issue and the patient was instructed to go to the emergency room.No further information is available at this time.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6547643
• MDR Text Key: 74546334
• Report Number: 2938836-2017-23583
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: CD3249-40Q
• Device Lot Number: 3706806
• Other Device ID Number: 05414734504546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2012
• 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 Age: 83 YR