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

Model Number 1056T/86

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

Related manufacture reference number: 2017865-2023-11342.Related manufacture reference number: 2017865-2023-11343.It was reported that the patient presented during clinic follow-up.Upon interrogation, it was noted that the right ventricular lead exhibited high defibrillation impedance.During explant procedure, it was noted that the atrial lead, right ventricular lead, and left ventricular lead were dislodged potentially due to twiddler's syndrome.All lead were explanted on (b)(6) 2023.During explant, the tip of the left ventricular lead broke off.The patient was in stable condition.

Manufacturer Narrative

The reported event of lead dislodgement and break were not confirmed.As received, a partial lead was returned in two pieces for analysis.Electrical testing and visual inspection did not identify any anomalies.

• Brand Name: QUICKSITE LV
• 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: 16454871
• MDR Text Key: 310374795
• Report Number: 2017865-2023-11344
• Device Sequence Number: 1
• Product Code: OJX
• 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: 03/21/2023

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 Expiration Date: 03/31/2009
• Device Model Number: 1056T/86
• Device Lot Number: 0002207765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2006
• 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: UNIFY ASSURA
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 115 KG