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

Model Number CD3369-40Q

Device Problems Premature Discharge of Battery (1057); Capturing Problem (2891)

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

Event Date 11/02/2023

Event Type  Injury  

Event Description

It was reported that patient presented in clinic for routine follow-up.Upon interrogation, it was found that patient's implantable cardioverter defibrillator (icd) exhibited premature battery depletion.High threshold was also noted.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

The report event of premature battery depletion was confirmed.The report event of inadequate capture was not confirmed.Upon receipt, the device was unable to be interrogated.The loss of communication was due to low battery voltage.The device was analyzed and premature battery depletion was confirmed.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions were tested and found to be normal.Electrical testing revealed high current drain from the hybrid.An anomalous hybrid was found to be the root cause of the high current drain and premature battery depletion.

• 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: 18166086
• MDR Text Key: 328478271
• Report Number: 2017865-2023-72566
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• 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,Followup
• Report Date: 05/15/2024

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: 11/30/2023
• Device Model Number: CD3369-40Q
• Device Lot Number: A000118094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/17/2024; 05/03/2024
• Supplement Dates FDA Received: 01/17/2024; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2021
• 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
• Treatment: QUARTET; RIGHT VENTRICULAR LEAD; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG