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

Model Number CD3265-40Q

Device Problems Delayed Charge Time (2586); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2020-01100.It was reported that the patient presented with right ventricular lead exhibiting high capture thresholds.The long charge time and high capture thresholds were also exhibited by the implantable cardioverter defibrillator; although the elective replacement indicator had been reached.The right ventricular lead was capped and replaced on (b)(6) 2019.The device was also replaced during the procedure.The patient was in stable condition.

Manufacturer Narrative

The reported events of long charge time and high pacing threshold could not be verified.The longest charge time recorded in the device¿s lifetime charge log was normal and within specifications.A capacitor maintenance was performed in the laboratory, and the charge time was also normal.The device¿s sensing, pacing, lead impedance, high voltage charging, high voltage delivery and high voltage shock impedance were tested, and the device¿s function was normal.

• 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: 9639979
• MDR Text Key: 176756822
• Report Number: 2017865-2020-01096
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: CD3265-40Q
• Device Catalogue Number: CD3265-40Q
• Device Lot Number: 4266915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• 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: 73 YR
• Patient Weight: 68