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

Model Number CD3261-40

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/02/2014

Event Type  Injury  

Event Description

It was reported that the patient was brought to the hospital after losing consciousness.Evaluation showed four asystolic episodes.Appropriate therapy was delivered to the patient, after which there was a pause of 27 seconds.The device was programmed to doo.Four days later the patient presented for follow-up.Device interrogation showed all electrical measurements were normal and trends were stable.The physician elected to explant and replace the system.There were no further adverse consequences to the patient following this event.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.(b)(4).Evaluation description: the device was tested on the bench and no anomalies were found.

• 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: cary lawler ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184932621
• MDR Report Key: 4021755
• MDR Text Key: 4844010
• Report Number: 2938836-2014-14384
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: CD3261-40
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2013
• 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
• Treatment: (B)(4), (B)(4), (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 66