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

Model Number CD3267-40

Device Problems High impedance (1291); Failure to Convert Rhythm (1540); Under-Sensing (1661)

Patient Problems Syncope (1610); Fainting (1847); Ventricular Tachycardia (2132)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported defibrillation threshold testing led to failed shocks during a true vt and did not terminate shocks appropriately.The patient loss consciousness during vt and fell down.When the patient fell down, he hit his head.The patient remained in the hospital for a couple of weeks.A programming change and dft testing revealed undersensing r-waves.A pc shock was delivered and reverted the pateint to sinus.Another programming and dft testing attempt repeated the same issues and did not convert the patient.Finally, a third programming change converted the patient to normal sinus.This led to the patient going into vt and the device delivering delayed therapy.The shocking vector could not be adjusted as upper out of range hvli measurements were recorded indicating a possible circuit break.New programming changes were made to the max outputs and the max sensitivity.The patient will return to the clinic in (b)(6) for more exercises.No adverse consequences were detected.

• 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: 5031598
• MDR Text Key: 24099270
• Report Number: 2938836-2015-29107
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/29/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: CD3267-40
• Device Lot Number: 3941757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2013
• 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: 78 YR