MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA CRT-D QUAD RF HV; NO MATCH

Model Number CD3365-40Q

Device Problems Failure to Convert Rhythm (1540); Inappropriate or Unexpected Reset (2959)

Patient Problem Arrhythmia (1721)

Event Date 12/19/2023

Event Type  Injury  

Event Description

It was reported that a patient presented with back-up vvi mode noted on the patient's implantable cardioverter defibrillator.Additionally, during a sustained ventricular fibrillation episode, the device was unable to convert the rhythm and external defibrillation was needed.No further intervention or adverse patient consequences were reported.

Manufacturer Narrative

Correction: h6: field should reflect life threatening injury.Correction: b2: field should reflect life threatening injury code.

• Brand Name: QUADRA ASSURA CRT-D QUAD RF HV
• 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: 18460604
• MDR Text Key: 332251908
• Report Number: 2017865-2024-00568
• Device Sequence Number: 1
• Product Code: NIK
• 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,Followup
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: CD3365-40Q
• Device Lot Number: 4624000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2014
• 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: DURATAACTIVE; QUARTETLEADS; TENDRIL STS
• Patient Outcome(s): Required Intervention; Life Threatening; Other
• Patient Age: 85 YR
• Patient Sex: Female