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

Model Number CD3361-40QC

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Contamination with Body Fluid (2317); Contamination of Device Ingredient or Reagent (2901)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the device delivered several inappropriate shocks due to noise and oversensing on the right ventricular (rv) channel.There was also noise present on the left ventricular (lv) and right atrial (ra) channels.Technical support was contacted, and there was also high impedance noted in all three channels as well.The device was explanted and replaced, and during the procedure, there was bodily fluid noted in the device header.The patient was stable following the procedure.

Manufacturer Narrative

The reported events of noise, oversensing, inappropriate therapy, and high defibrillation impedance were confirmed via reviewing of the device image.Noise was seen on both of the stored egms and on real-time egm.The device was tested in the laboratory, and noise was also observed during testing.It is believed noise was caused by an unregulated internal supply voltage.The unregulated supply voltage was caused by an intermittent capacitor¿s connection in the hybrid.As a result of this finding, abbott is performing further investigation for connection anomaly with hybrid capacitor c10.Additional findings observed during analysis that are unrelated to the reported event.Premature battery depletion was confirmed by analysis.A device evaluation was performed, and no sources of high current were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10186568
• MDR Text Key: 196160257
• Report Number: 2938836-2020-06855
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: CD3361-40QC
• Device Lot Number: 4854425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0116-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention