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

Model Number CD3369-40Q

Device Problems Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 07/25/2020

Event Type  malfunction  

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 Description

It was reported the patient presented to the emergency room after getting a vibratory alert and feeling thumping in their chest.Upon further investigation, it was observed the implantable cardioverter defibrillator was in backup pacing mode and receiving high outputs leading to intermittent phrenic nerve stimulation.The device was restored successfully and a cyber security update was completed to prevent this issue in the future.The patient was discharged.

• 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: 10409464
• MDR Text Key: 202988676
• Report Number: 2017865-2020-11339
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000031727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2016
• 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 Age: 84 YR