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

Model Number 1458Q/75

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that the patient experienced discomfort due to diaphragmatic stimulation.The pacemaker was explanted on (b)(6) 2023.There were no patient consequences.

Event Description

Additional information received noted that the left ventricular lead was the cause of the diaphragmatic stimulation.There were no allegation on the pacemaker.The left ventricular lead remains implanted.The patient was in stable condition.

• Brand Name: QUARTETLEADS_U_PR
• 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: 18514449
• MDR Text Key: 332869185
• Report Number: 2017865-2024-01200
• Device Sequence Number: 1
• Product Code: NIK
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 1458Q/75
• Device Lot Number: A000036139
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• 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: QUARTET LEAD; TENDRIL LEAD; TENDRIL LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female