MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ASSURA DDQP+; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3267-40Q

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Programming Issue (3014)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/07/2018

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

The patient presented in the clinic after receiving an inappropriate shock.Upon interrogation, there were episodes of atrial oversensing noted due to noise on the atrial lead.The noise was reproducible with lead provocative testing.There were also episodes of inappropriate automated mode switch (ams) noted due to the noise.The shock was delivered due to the noise on the atrial lead not being appropriately discriminated due to programming.The device was reprogrammed to resolve the event and the patient was stable.Related manufacturer report number: 2017865-2018-09684.

• Brand Name: QUADRA ASSURA DDQP+
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7655325
• MDR Text Key: 112906521
• Report Number: 2938836-2018-08344
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: CD3267-40Q
• Device Lot Number: 3880807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2012
• 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
• Treatment: 1882TC/52, CWG021626
• Patient Outcome(s): Hospitalization; Required Intervention