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

Model Number CD3265-40Q

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/19/2018

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 the patient presented to the emergency room after receiving two inappropriate high voltage shocks from their implantable cardioverter defibrillator.The device had delivered shocks due to atrial fibrillation with a fast-ventricular response.The patient was admitted to the hospital for observation and medication adjustment.The last shock had converted the patient from atrial fibrillation to sinus rhythm.The patient would continue to be monitored.

• Brand Name: QUADRA ASSURA (DDQP+)
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8205089
• MDR Text Key: 131695563
• Report Number: 2017865-2018-19787
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: CD3265-40Q
• Device Catalogue Number: CD3265-40Q
• Device Lot Number: 4090537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2013
• 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): Hospitalization
• Patient Age: 74 YR