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

Model Number 1458Q/86

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Arrhythmia (1721)

Event Date 03/06/2024

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2024-35777.Related manufacturer reference number: 2017865-2024-35778.It was reported that the patient presented to the emergency department with a heart rate in the 40¿s.A chest x-ray was performed showing that the patient had twisted the device so many times that it pulled all three leads out of the heart and all the way back to the shoulder.No electrical anomalies were observed.The leads were explanted and new leads were implanted.There were no adverse health consequences, the patient was stable.

Manufacturer Narrative

The reported event was lead dislodgement.As received, a complete lead was returned in one piece for analysis.The s-curve height was measured to be within specification.Electrical testing did not find conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies except procedural damage.

• 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: 18968125
• MDR Text Key: 338483264
• Report Number: 2017865-2024-35779
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• 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: 05/20/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000132877
• 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: 03/06/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2022
• 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 ALLURE.
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female