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

Model Number CD3367-40QC

Device Problem Connection Problem (2900)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that during an unrelated procedure, the patient's implantable cardioverter defibrillator was unable to connect to the lead.The device was removed and replaced on (b)(6) 2024.The patient was stable throughout.

Manufacturer Narrative

The reported field event of lead connection issue was confirmed.The device was above elective replacement indicator (eri) when received.Analysis revealed the rv (df4) set screw was backed out from its thread as a result of unscrewing the set screw too far.When the screw was re-engaged with the connector block, the screw operated normally in affixing the test lead to the header.The connection anomaly was consistent with having occurred during the procedure.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: QUADRA ASSURA 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: 18872363
• MDR Text Key: 337294587
• Report Number: 2017865-2024-34510
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: CD3367-40QC
• Device Lot Number: P000134345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2021
• 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