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

Model Number CD3257-40

Device Problems No Device Output (1435); Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 09/05/2014

Event Type  Death  

Event Description

It was reported that the patient experienced a true vf arrest.The device detected the episode and delivered one high voltage therapy that was unable to convert the rhythm.The device proceeded to detect the ongoing vf episode, however, the device alerted for possible high voltage circuit damage and failed to charge for high voltage therapy delivery.Emergency external defibrillation and intubation were required.The patient was in hospice care at the time of the arrest and was sent to the icu.It was later noted that the patient was extubated and coherent enough to decide to turn device high voltage therapy off.Review of egms revealed a mixture of vf and lead noise on all three channels.Programming changes were recommended.It was later reported the patient expired.The patient was in hospice care due to end stage heart failure.It is unknown whether the patient expired due to a direct or indirect result of the device failing to deliver therapy.

Manufacturer Narrative

• Brand Name: UNIFY ASSURA CRT-D
• 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: 4133704
• MDR Text Key: 16085981
• Report Number: 2938836-2014-16274
• 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

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: 11/30/2013
• Device Model Number: CD3257-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2014
• Initial Date FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2012
• 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
• Treatment: 1581/60, RG12294
• Patient Outcome(s): Death
• Patient Age: 67 YR