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); High impedance (1291)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 2017865-2020-12508.It was reported that the left ventricular (lv) lead exhibited high pacing impedance and loss of capture.During lead revision procedure, it was noted that the set screw on the implantable cardioverter defibrillator (icd) would not tighten after the new lead was placed, it was suspected that the lv header on the device could have resulted in the anomalies.The icd and lv lead were explanted and replaced.The patient was in stable condition before, during, and after the procedure.

Manufacturer Narrative

The reported events of high impedance and unable to capture the left ventricular was confirmed.A complete lead was returned in three pieces.Analysis found the ring electrode cable broken 26.2 cm and at 32.5 cm from the distal tip.The cause of the reported events was isolated to the broken right electrode cable.

• 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: 10529319
• MDR Text Key: 206794905
• Report Number: 2017865-2020-12509
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 05414734502610
• UDI-Public: 05414734502610
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: 3386357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNIFY ASSURA CRT-D RF HV; UNIFY ASSURA CRT-D RF HV
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR