MAUDE Adverse Event Report: ABBOTT QUADRA ASSURA MP ICD; No Match

Model Number CD3371-40QC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2024

Event Type  Death  

Event Description

Related manufacturer report number 2017865-2024-34567 it was reported that inadequate capture, high pacing impedance, and r-wave amplitude variation were noted on the right ventricular (rv) lead.The physician suspected rv lead damage, however, no lead anomaly was observed either visually nor via diagnostic imaging.A revision procedure was performed with the intention of replacing the rv lead and downgrade the device due to the condition of the patient.There was no allegation on the device.During the procedure, pericardial effusion was noted by the physician due to cardiac perforation in the right auricle.The physician does not suspect the performance of the rv lead caused nor contributed to the cardiac perforation.The patient experienced low blood pressure and the ventricle was collapsed with blood.The cardiac surgeon attended and intervention was performed including cardiac massage, medication including adrenaline, and blood transfusions.The chest was opened, a break in the right auricle was observed and attempts to resolve where attempted.The patient passed away with the cause of death being attributed to the cardiac perforation resulting in pericardial effusion and collapse of the heart.

• Brand Name: QUADRA ASSURA MP ICD
• 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: 18951130
• MDR Text Key: 338258310
• Report Number: 2017865-2024-34569
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: CD3371-40QC
• Device Lot Number: A000102936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• 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
• Treatment: COOK MEDICAL GUIDE LIBERATOR AND SHEATH
• Patient Outcome(s): Death