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

Model Number CD3265-40Q

Device Problems Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)

Patient Problems Fainting (1847); Ventricular Tachycardia (2132)

Event Date 07/05/2019

Event Type  malfunction  

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 had a cardiac event while working out on the treadmill and passed out.Upon interrogation, the device showed monomorphic vt that was diagnosed correctly, but after antitachycardia pacing (atp) while charging was delivered, the rate slowed below the vf zone.The patient then went into polymorphic vt and undersensing occurred due to high/low amplitude signals.Patient was given cardiopulmonary resuscitation and externally shocked at the scene which converted him to sinus.Patient then went into another round of vt/vf; the device diagnosed correctly and shocked him successfully to sinus.The recommended programming changes were made to make the device more sensitive to polymorphic events in the future.The patient was stable after the changes were made.

• Brand Name: QUADRA ASSURA (DDQP+)
• 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: 8810207
• MDR Text Key: 151715221
• Report Number: 2938836-2019-06188
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734505673
• UDI-Public: 05414734505673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: CD3265-40Q
• Device Catalogue Number: CD3265-40Q
• Device Lot Number: 3695978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2019
• Initial Date FDA Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2012
• 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 Age: 91 YR