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

Model Number CD3365-40Q

Device Problem Insufficient Information (3190)

Patient Problems Dizziness (2194); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter defibrillator exhibited some abnormalities and complications.The implantable cardioverter defibrillator was explanted on (b)(6) 2023.The patient's condition was unknown.

Manufacturer Narrative

Voluntary event report was received.Medwatch: mw5119759.

Manufacturer Narrative

The device was returned due to performance issue.As received, a device was returned for analysis.Telemetry, sensing, pacing, pacing lead impedance, and high voltage (hv) output functions of the device were tested.No anomaly was detected.

Event Description

Additional information received noted that the patient was symptomatic of nausea.

• 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: 17628950
• MDR Text Key: 322018770
• Report Number: 2017865-2023-39370
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508292
• UDI-Public: 05414734508292
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: CD3365-40Q
• Device Lot Number: 4534478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2014
• 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: BOSTON SCIENTIFIC RV LEAD; QUARTET LEAD; TENDRIL LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male