MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Fall (1848); Loss of consciousness (2418)

Event Date 02/16/2016

Event Type  Death  

Manufacturer Narrative

Maude report, mw506949, was received.

Event Description

It was reported that patient had expired.Device was implanted three years before the event.It was reported that patient bent over and was preparing to receive shock from the device, and defibrillator failed to shock.Patient tried to walk and fell on the floor.Ambulance took significant amount of time to arrive due to snow storm and patient became unresponsive.Patient was declared deceased by the doctor at hospital.No further information is available at this time.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• 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: 6630232
• MDR Text Key: 77219727
• Report Number: 2938836-2017-25347
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/09/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: CD3249-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death