MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; NO MATCH

Model Number CD3371-40QC

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383)

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

Event Date 11/30/2023

Event Type  Injury  

Event Description

It was reported that the device reached its elective replacement indicator (eri) prematurely.The date the device reached eri was not available.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported event of premature battery depletion could not be confirmed.Review of the device data did not show any indication of the device reaching its elective replacement indicator (eri).Therefore, the reported event of eri alert with no date could not be confirmed.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Telemetry, impedance, sensing, pacing and hv output functions of the device were tested and found to be normal.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18319218
• MDR Text Key: 330389947
• Report Number: 2017865-2023-94679
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: CD3371-40QC
• Device Lot Number: 4633732
• 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 Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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
• Patient Outcome(s): Required Intervention