MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40QC

Device Problems Inappropriate or Unexpected Reset (2959); Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

It was reported that the device was programmed into magnetic resonance imaging (mri) mode prior to mri exposure.The patient underwent an mri and the device was in backup vvi mode with no backup defibrillation support available following the mri.Technical support was contacted and the device was reprogrammed to resolve the event.The patient was stable and will continue to be monitored.

Event Description

Additional information received indicated the device was explanted due to normal elective replacement.

Manufacturer Narrative

The reported event of backup operation was confirmed.Analysis of device image revealed the device went into backup mode due to a power on reset.The device was successfully restored from backup mode in the field.Functional testing was performed and the telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were observed to be normal.The backup operation could not be reproduced.Additionally, a software investigation was performed and the root cause of the power on reset could not be determined.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13416463
• MDR Text Key: 284825665
• Report Number: 2017865-2022-02272
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: CD3371-40QC
• Device Lot Number: 4765780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2014
• 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