MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE

Model Number 1458Q/86

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  Injury  

Event Description

It was reported that a patient presented in clinic for a surgical revision procedure.Prior examination of the left ventricular (lv) lead revealed dislodgement, which was confirmed with x-ray imaging.During the procedure, the suture sleeve was found to have moved, and was not able to hold the lead in its original position.The lv lead was explanted and replaced on (b)(6) 2023.The patient was stable throughout.

Manufacturer Narrative

The reported events were lead dislodgement and suture sleeve movement.As received, a complete lead was returned in one piece for analysis.The reported event of suture sleeve movement was not confirmed.The inner and outer diameters inside of the suture sleeve were found to be within specification.Visual and x-ray inspections of the lead did not find any anomalies but found the suture sleeve to be cut consistent with procedural damage.The s-curve hump height was within specification.Electrical testing did not find any indication of conductor fractures or internal shorts.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 16533491
• MDR Text Key: 311203836
• Report Number: 2017865-2023-13620
• 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: 03/29/2023

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 Catalogue Number: 1458Q-86
• Device Lot Number: A000128863
• 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: 02/23/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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: GALLANT HF; OPTISURE MRI; TENDRIL LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male