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

Model Number CD3367-40QC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Palpitations (2467)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that when the patient presented to clinic after feeling unwell and experiencing palpitations, several alerts indicating pacemaker-mediated tachycardia (pmt) were observed.Egms were turned off for pmt so there were no egms to review.Device was reprogrammed.There were also some unrelated non sustained rv oversensing episodes due to emi probably due to nerve stimulation unit patient is using on the back.Further information is not available at this time.

Event Description

New information received notes that patient returned home post programming changes and was directed to call the clinic if symptoms re-occurred.Merlin home monitoring device also given and patient directed to send manual transmission and notify clinic if symptoms return.The patient remains stable with no complaints.

• Brand Name: QUADRA ASSURA ICD
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8201688
• MDR Text Key: 131582194
• Report Number: 2938836-2018-13364
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

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 Expiration Date: 03/31/2018
• Device Model Number: CD3367-40QC
• Device Lot Number: S000018078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2016
• 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
• Patient Age: 74 YR