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

Model Number CD3267-40Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problems Syncope (1610); Fall (1848); Hemorrhage/Bleeding (1888); Ventricular Fibrillation (2130)

Event Date 04/28/2020

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 syncopal falling and caused a subdural hemorrhage.The patient was admitted to the hospital and it was seen that the patient had true ventricular tachycardia and had received anti-tachycardia pacing therapy that accelerated the rhythm to ventricular fibrillation.The patient received a shock in attempt to correct the arrhythmia.No programming changes have been made at this time.The physician does not allege the device of any malfunction, rather that it was incorrect programming for the patient's rhythm.The patient was reported stable.

• 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
• MDR Report Key: 10044506
• MDR Text Key: 190545426
• Report Number: 2017865-2020-05872
• 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: Physician
• Type of Report: Initial
• Report Date: 05/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: CD3267-40Q
• Device Lot Number: 3824788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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 Outcome(s): Life Threatening; Other