MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3361-40C

Device Problems No Device Output (1435); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Syncope (1610); Collapse (2416); Shock from Patient Lead(s) (3162)

Event Type  Injury  

Manufacturer Narrative

(b)(4).No conclusion code available.The reported oversensing was confirmed in the laboratory via review of the attached electrograms.The device was tested on the bench as well as using automated test equipment, and a damaged septum was noted.The cause of the damage could not be determined.

Event Description

It was reported slightly after a device changeout, patient returned to the hospital after collapsing for noted periods of asystole.Electrograms revealed inhibition of pacing due to lead noise.Blood fluids were seen from the lead ports after the leads were removed and reconnected.After lead swapping, it was concluded the issue was a result from damage to the device header.The device had an aborted shock when lead noise stopped.A programming change was made and the defibrillation therapies were turned off for the time being.The device was later explanted and replaced.The patient condition was stable.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5638858
• MDR Text Key: 44663907
• Report Number: 2938836-2016-03587
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2016

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: 09/30/2017
• Device Model Number: CD3361-40C
• Device Lot Number: P000016246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2016
• Initial Date FDA Received: 05/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2015
• 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): Required Intervention