MAUDE Adverse Event Report: ST. JUDE MEDICAL OPERATIONS (M) SDN BHD UNIFY ASSURA ICD; No Match

Model Number CD3361-40C

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that the patient's implantable cardioverter defibrillator failed to record the atrial echocardiogram during delivery of high voltage therapy for true ventricular fibrillation (vf).No intervention was performed.There were no patient consequences.

• Brand Name: UNIFY ASSURA ICD
• Type of Device: No Match
• Manufacturer (Section D): ST. JUDE MEDICAL OPERATIONS (M) SDN BHD; plot 102, lebuhraya kampung jawa; bayan lepas industrial zone; penang, pulau pinang 11900 ; MY 11900
• Manufacturer (Section G): ST. JUDE MEDICAL OPERATIONS (M) SDN BHD; plot 102, lebuhraya kampung jawa; bayan lepas industrial zone; penang, pulau pinang 11900 ; MY 11900
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18004605
• MDR Text Key: 326770396
• Report Number: 3008377825-2023-00015
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2023

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: 05/31/2019
• Device Model Number: CD3361-40C
• Device Lot Number: P000045836
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• 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 Age: 82 YR
• Patient Sex: Male