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

Model Number CD3371-40QC

Device Problem Over-Sensing (1438)

Patient Problem Dizziness (2194)

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for a routine check in clinic.The patient reported that he gets dizzy when lifting items above his head and demonstrated the manoeuvre.Oversensing on the implantable cardioverter defibrillator (icd) and right ventricular (rv) lead due to noise was observed, but the patient was asymptomatic to the manoeuver.Non sustained oversensing due to noise had also been observed (b)(6) 2023 but the patient did not recall having any symptoms.Atrial lead noise resulting in auto mode switching was also observed.Programming changes to right ventricular sensing was made.The patient was stable before, during and after the programming changes.

• 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: 17705821
• MDR Text Key: 323161882
• Report Number: 2017865-2023-42500
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 09/07/2023

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 Expiration Date: 04/30/2022
• Device Model Number: CD3371-40QC
• Device Lot Number: A000096413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• 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