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

Model Number CD3367-40C

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Over-Sensing (1438); No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2023-51253.It was reported that high defibrillation impedance and noise resulting in oversensing and pacing inhibition was observed on the right ventricular (rv) lead.Abbott technical support suspected the event was due to a set screw was too loose or that the lead was damaged.The revision procedure was performed and the cause of the event was determined to be a loose set screw.The rv lead was replaced due to the pacing inhibition and the device remained implanted with the new lead adequately fastened via the set screw.The patient was in stable condition.

• Brand Name: QUADRA ASSURA 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: 18043586
• MDR Text Key: 327017113
• Report Number: 2017865-2023-51254
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CD3367-40C
• Device Lot Number: P000136854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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