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

Model Number CD3367-40QC

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

Patient Problems Therapeutic Effects, Unexpected (2099); Ventricular Tachycardia (2132)

Event Date 12/18/2020

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 the patient presented in clinic.Upon interrogation, it was observed the patient went into atrial fibrillation with rapid ventricular conduction.The patient's implantable cardioverter defibrillator (icd) misread this as supraventricular tachycardia, and upon redetection misread it as ventricular tachycardia (vt).The icd then delivered anti-tachycardia pacing, which caused the rhythm to go into vt.The icd then delivered a shock, restoring the rhythm.Programming changes were suggested, but no intervention was performed.The patient was in stable condition.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 11152484
• MDR Text Key: 226236614
• Report Number: 2017865-2021-01097
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: CD3367-40QC
• Device Lot Number: S000019508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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): Other