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); Device Operates Differently Than Expected (2913)

Patient Problem Chest Pain (1776)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device did not give the patient therapy for a ventricular tachycardia rhythm of which the patient was symptomatic from.The device stored a non-sustained episode for a ventricular tachycardia due to several trashed beats that prevented vt detection.The rhythm was falling around the vt cutoff rate.Programming changes were made.The patient will return for follow up.

• Brand Name: QUADRA ASSURA (DDQP+)
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5320098
• MDR Text Key: 34164516
• Report Number: 2938836-2015-32414
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: CD3265-40Q
• Device Lot Number: 4149738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2013
• 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): Required Intervention
• Patient Age: 77 YR