MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; NO MATCH

Model Number 1458Q/75

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Fever (1858); Unspecified Infection (1930); Dizziness (2194)

Event Date 02/16/2024

Event Type  Injury  

Event Description

Related manufacturer reference number: (b)(6) it was reported that the patient admitted to the hospital for sepsis and leads vegetation.A non-invasive testing revealed non-specific lead vegetations.The patient was presented with symptom of sepsis including febrile presentation, light-headedness, tachycardia, and tachypnea.On 16feb2024, while receiving antibiotic therapy regimen, an unsuccessful attempt was made to obtain vascular access for implantation of a replacement system.The patient was maintained in an inpatient status and returned to the hospital for explant procedure on 19feb2024.No erosion was noted.The system- implantable cardioverter defibrillator (icd), right atrial lead, right ventricle lead and left ventricle lead was explanted.There is no allegation that the system or any procedure involving the system contributed or caused the infection.There were no patient consequences.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.

Manufacturer Narrative

Correction: the correct outcomes attributed to adverse should have been hospitalization- initial or prolonged and required intervention to prevent permanent impairment/ damage (devices), rather than required intervention to prevent permanent impairment/ damage (devices) only.

• Brand Name: QUARTET
• 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: 18765241
• MDR Text Key: 336049644
• Report Number: 2017865-2024-33330
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 1458Q/75
• Device Lot Number: A000053115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• 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: QUADRA ASSURA MP ICD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White