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); Failure to Convert Rhythm (1540); Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411)

Event Date 01/12/2024

Event Type  Injury  

Event Description

It was reported the patient presented to the emergency room due to loss of consciousness and tachycardia.The patient did not feel shocks being delivered from the device and received cardiopulmonary resuscitation.The implantable cardioverter defibrillator (icd) exhibited premature battery depletion and inadequate high voltage therapy.The implantable cardioverter defibrillator (icd) was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of inadequate high voltage (hv) output and premature battery depletion could not be confirmed.The implantable cardioverter defibrillator (icd) was returned for analysis.Visual inspection of the device did not reveal any anomaly that could contribute to the reported event.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.A longevity calculation was performed and found the battery depletion was normal based on the device usage.

Event Description

Additional information received noted the implantable cardioverter defibrillator (icd) exhibited undersensing.

• 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: 18778067
• MDR Text Key: 336216363
• Report Number: 2017865-2024-33450
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

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: 09/30/2020
• Device Model Number: CD3369-40Q
• Device Lot Number: A000065678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/05/2024; 04/25/2024
• Supplement Dates FDA Received: 04/10/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2018
• 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: DURATA; QUARTET; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 57 KG