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

Model Number 1458Q/86

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Discomfort (2330); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/03/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, the patient experienced diaphragmatic stimulation from the left ventricular lead resulting in discomfort.The lead was not used, and no other lead was implanted.The patient condition was stable post-procedure.

Manufacturer Narrative

Correction: update b5 and h6 coding.

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, the patient experienced diaphragmatic stimulation from the left ventricular lead when placed on the target vessel.The operation was prolonged, and the patient developed heart failure.The lead was not used, and no other lead was implanted.The patient condition was stable post-procedure.

Manufacturer Narrative

The reported event was muscle stimulation.As received, a complete lead was returned in one piece.Electrical, visual and x-ray examination was normal with no anomalies found.

• 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: 18517986
• MDR Text Key: 332927319
• Report Number: 2017865-2024-01246
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1458Q/86
• Device Lot Number: A000141747
• 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: 01/03/2024
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2023
• 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