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

Model Number CD3371-40QC

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 2938836-2020-07883.Patient was presented in clinic after receiving inappropriate shocks.Upon investigation, noise resulting in oversensing was observed on the right ventricular (rv) channel.The device and the rv lead were explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of inappropriate therapy due to oversensing was not replicated in the laboratory.The device¿s sensing, pacing, lead impedance, high voltage charging, high voltage delivery and high voltage shock impedance were tested, and the device¿s function was normal.The device¿s associated lead was returned and analyzed, and no anomaly was found.The device¿s stored egms were reviewed and an egm recorded on (b)(6) 2020 showed p-waves being sensed on the ventricular sensing channel; this is consistent with lead dislodgement which was reported in 2938836-2020-07883.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10431762
• MDR Text Key: 203687751
• Report Number: 2938836-2020-07941
• 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: 10/28/2020

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: 06/30/2022
• Device Model Number: CD3371-40QC
• Device Lot Number: P000104362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTISURE ACTIVE FIXATION; OPTISURE ACTIVE FIXATION
• Patient Outcome(s): Required Intervention