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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic to have their left ventricular (lv) lead revised.It was noted that the lv lead was deactivated prior to this event due to diaphragmatic stimulation.The lv lead was explanted and replaced successfully.The patient was stable throughout the procedure.

Manufacturer Narrative

The lead was returned due to extra cardiac stimulation.As received, a complete lead was returned in one piece.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found an external insulation abrasion breaching two ring electrode cable lumens were noted at 56.9 cm to 57.1 cm from the connector pin consistent with friction to another implanted device or feature of the patient anatomy.The etfe coating cables and inner coil lumen were intact in this location.

Manufacturer Narrative

Corrected data: g3 - date received by manufacturer, updated from 01 feb 2024 to 18 jan 2024.

• 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: 18389990
• MDR Text Key: 331287872
• Report Number: 2017865-2023-95540
• 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,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1458Q/86
• Device Lot Number: A000099831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• 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: 1888TC/52US.; QUADRAASSURA MP ICD UMRI.; SVC 21CM,DURATA 7F/ST, ACT TRU.
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female