MAUDE Adverse Event Report: ABBOTT UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP; NO MATCH

Model Number CD3251-40Q

Device Problem Over-Sensing (1438)

Patient Problems Dyspnea (1816); Discomfort (2330); Syncope/Fainting (4411)

Event Date 11/10/2023

Event Type  Injury  

Event Description

It was reported that during a follow up in clinic, myopotential oversensing resulting in pacing inhibition was noted on the device resulting in pacing inhibition.The patient experienced syncope, dyspnea, and nausea, however, it is unknown if the symptoms were related to the oversensing.Abbott technical support was contacted and reprogramming of the device was recommended.No intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

Event Description

It was reported that during a follow up in clinic, myopotential oversensing resulting in pacing inhibition was noted on the device resulting in pacing inhibition.The patient experienced syncope, dyspnea, and nausea, however, it is unknown if the symptoms were related to the oversensing.Abbott technical support was contacted and the device was reprogrammed.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP
• 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: 18184126
• MDR Text Key: 328694570
• Report Number: 2017865-2023-72855
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 02/23/2024

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: 09/30/2016
• Device Model Number: CD3251-40Q
• Device Lot Number: S000004193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 11/21/2023; 02/23/2024
• Supplement Dates FDA Received: 11/21/2023; 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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; Other