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

Model Number 1258T/86

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problem Syncope/Fainting (4411)

Event Date 04/10/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital for a follow-up on (b)(6) 2023 with syncope.During examination of lead, it was noted that there was no capture threshold on the left ventricular (lv) lead.After further assessment in clinic, fluoroscopy confirmed lv lead dislodgement.The lv lead was explanted and replaced on (b)(6) 2023.The patient was in stable condition.

Manufacturer Narrative

The reported event of failure to capture was not confirmed.A full lead was returned in one piece for analysis.Specification measurements, visual inspection, x-ray examination and electrical testing were normal with no anomalies found.

Manufacturer Narrative

Correction: h10 - manufacturer narrative in mdr-2023-18896-01 submitted on 22 jun 2023 should have been: the reported event of failure to capture was not confirmed.A full lead was returned in one piece for analysis.Specification measurements, visual inspection, x-ray examination and electrical testing were normal with no anomalies found.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: QUICKFLEX MICRO LV LEAD
• 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: 16841427
• MDR Text Key: 314259484
• Report Number: 2017865-2023-18765
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: 05414734502610
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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,Followup
• Report Date: 06/22/2023

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: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: A000123399
• 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: 04/10/2023
• Initial Date FDA Received: 04/30/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 06/22/2023
• Supplement Dates FDA Received: 06/22/2023; 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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
• Patient Outcome(s): Required Intervention