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

Model Number CD3371-40QC

Device Problems Failure to Charge (1085); Inappropriate or Unexpected Reset (2959)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  Injury  

Event Description

It was reported the patient presented in clinic for follow-up.Upon review it was noted that the implantable cardioverter defibrillator was in backup vvi mode.The device was restored.Upon further testing the capacitor failed to charge.The patient was in stable condition.

Event Description

New information notes that the device was explanted and returned.

Event Description

New information notes that the patient had an infectious event, for which the procedure was postponed.The device was later explanted because it entered security mode and was indicated that the capacitor and the battery were compromised.The patient was stable.

Event Description

New information notes that the cause of the infection was of peritoneal origin due to a dialysis process.The infection was not related to the products.

Manufacturer Narrative

The reported event of backup operation and charge timeout was confirmed.Analysis of device image found the device went into backup mode due to power-on-reset from excessive charges.Charge timeout was due to low battery voltage from excessive charges.The device image was reviewed by tech services and confirmed the device behaved as programmed.After the device was restored from backup mode, functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.A longevity calculation was performed and found the battery depletion was normal based on the device usage.

• Brand Name: QUADRA ASSURA MP ICD
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15491721
• MDR Text Key: 305515972
• Report Number: 2017865-2022-39399
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/24/2023

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: 06/30/2023
• Device Model Number: CD3371-40QC
• Device Lot Number: A000110974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/27/2022
• Supplement Dates Manufacturer Received: 10/24/2022; 11/09/2022; 11/22/2022; 01/23/2023
• Supplement Dates FDA Received: 11/01/2022; 11/19/2022; 11/22/2022; 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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