MAUDE Adverse Event Report: ABBOTT UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3251-40Q

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The patient presented in clinic due to acute decomposition.The device was interrogated which displayed several episodes of inappropriate therapy and antitachycardia pacing therapy being delivered to the patient.The device was reprogrammed to resolve the event.Ultimately the device was replaced due to normal battery depletion.The patient was stable.

• Brand Name: UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10347664
• MDR Text Key: 201352788
• Report Number: 2938836-2020-07732
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2020

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: 02/28/2014
• Device Model Number: CD3251-40Q
• Device Lot Number: 3788713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2012
• 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): Other