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

Model Number CD3367-40QC

Device Problem Premature Discharge of Battery (1057)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

The device is included in the premature battery depletion with implantable cardioverter defibrillator advisory notice issued by st.Jude medical on 11 october 2016.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an in-clinic follow up, premature battery depletion was suspected on the device.The device was explanted and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

Interrogation of the device revealed the device was at elective replacement indicator (eri) when received.There was no detection of a battery performance alert (bpa) noted.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Based on this information, there was no evidence of premature depletion.

• Brand Name: QUADRA ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11177876
• MDR Text Key: 227041229
• Report Number: 2017865-2021-02178
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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: 06/30/2016
• Device Model Number: CD3367-40QC
• Device Lot Number: 4680132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 03/14/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention