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 Problems Arrhythmia (1721); Dyspnea (1816); Discomfort (2330)

Event Date 12/19/2023

Event Type  Injury  

Event Description

It was reported that postoperative chest tightness, shortness of breath, a fast heart beat evident when lying on the left side and discomfort was observed following initial implant.The physician indicated the left ventricular (lv ) lead was dislodged.On dec 19, 2023 the lv lead was explanted and replaced.Parameters post surgery were stable, no discomfort was observed after surgery and significant improvement was observed.

Manufacturer Narrative

The reported event was lead dislodgement.As received, a complete lead was returned in one piece.The s-curve hump height was measured within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.Visual examination found no anomalies.

• 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: 18427237
• MDR Text Key: 331772134
• Report Number: 2017865-2024-00084
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734503198
• UDI-Public: 05414734503198
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2024

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 Model Number: 1458Q/86
• Device Lot Number: A000129613
• 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: 12/19/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/03/2024; 02/06/2024
• Supplement Dates FDA Received: 01/23/2024; 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2022
• 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
• Patient Outcome(s): Required Intervention