MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; No Match

Model Number CD3369-40C

Device Problems Loose or Intermittent Connection (1371); Over-Sensing (1438)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

Related manufacturer report #:2017865-2023-42333 it was reported that non sustained right ventricular oversensing due to noise signals causing brief pacing inhibition was observed on the right ventricular (rv) lead.The noise was noted to occur subsequent to a recent generator change and was not present on the original generator.A possible fracture of the rv lead or set screw issue was suspected.The noise could not be programmed around.A revision was discussed.There were no reported patient consequences.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: No Match
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17695680
• MDR Text Key: 322830026
• Report Number: 2017865-2023-42334
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508346
• UDI-Public: 05414734508346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3369-40C
• Device Lot Number: A000138807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2023
• 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: QUARTET LV LEAD.; TENDRIL RA LEAD.
• Patient Age: 81 YR
• Patient Sex: Female