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

Model Number	CD3265-40
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the implantable cardioverter defibrillator was in backup vvi mode.A device restoration was not successful.The device was pending explant.The patient was stable.
Event or Problem Description
New information notes that the device was explanted.The patient was stable before, during and after the procedure.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.Upon receipt, the device was not able to communicate due to low battery voltage.Analysis of the device image found the device performed numerous high voltage charges for high voltage therapy.The cause of backup operation and no communication was consistent with low battery voltage resulting from numerous high voltage charges.After the device was restored from backup mode, functional testing was performed.Telemetry, impedance, sensing, and pacing output functions of the device were tested and found to be normal.A longevity calculation was performed and the battery depletion was normal based on the device usage.

• Brand Name: QUADRA ASSURA (DDQP+)
• Common Device Name: 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 ; 8184932577
• MDR Report Key: 8970990
• Report Number: 2017865-2019-13411
• Device Sequence Number: 16816277
• Product Code: NIK
• UDI-Device Identifier: 05414734505666
• UDI-Public: 05414734505666
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: CD3265-40
• Device Catalogue Number: CD3265-40
• Device Lot Number: 3835977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2019
• Supplement Date Received by Manufacturer: 10/07/2019; 05/17/2024
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/09/2019; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male