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

Model Number 1258T/75

Device Problems Fracture (1260); High impedance (1291); Capturing Problem (2891); High Capture Threshold (3266)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This product is registered as a combination product.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented in clinic for a follow-up check.Upon review, the left ventricle lead exhibited high capture thresholds and high pacing impedance.Programming changes were made on the device.Patient was stable.

Event Description

New information notes that the patient was seen in clinic on 11 december 2020.Upon review, the left ventricle lead seemed fractured.Additionally, high pacing impedance and high capture thresholds were also noted.No new intervention was performed.No patient consequences.

• 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
• MDR Report Key: 11076424
• MDR Text Key: 223725850
• Report Number: 2017865-2020-23633
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502603
• UDI-Public: 05414734502603
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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: 03/31/2013
• Device Model Number: 1258T/75
• Device Catalogue Number: 1258T-75
• Device Lot Number: 3122230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR