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

Model Number CD3371-40QC

Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 06/22/2020

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 the patient experienced fast atrial tachycardia (at), atrial fibrillation (af) or atrial flutter and presented in clinic for a follow up.The episodes conducted through the ventricle and fell into the ventricular fibrillation (vf) zone.Therapy was delivered as the vf did not have any discriminators.These episodes occurred when patient was shoveling snow.The physician had asked the patient not exert that much physicals activity but he did not listen.Medication adjustment was considered rather than programming changes.The patient was stable.

Event Description

New information revealed the inappropriate therapy event occurred again due to incorrect interpretation of atrial rhythm.Programming changes were completed to address this issue.The patient was stable.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10231003
• MDR Text Key: 197551125
• Report Number: 2938836-2020-07250
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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: 06/30/2019
• Device Model Number: CD3371-40QC
• Device Lot Number: A000041586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/05/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other