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

Model Number 1258T/86

Device Problem Use of Device Problem (1670)

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

Event Date 12/01/2020

Event Type  malfunction  

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: 2017865-2020-23387.It was reported that the patient presented for an implant procedure.During the procedure, the physician was having difficulty implanting the left ventricular (lv) lead due to the poor angle of the target vessel.The inner cavity of the lead entered the blood, and the guidewire could not be inserted to the tip.The lead was removed and replaced.The 2nd lead was unable to enter the target blood vessel after more than a hour of trying.The 2nd lead was also removed and replaced.The patient was stable.

Manufacturer Narrative

The previously reported serial number (sn: (b)(4)) was incorrect.The correct serial number is (b)(4).

Manufacturer Narrative

As received, a complete lead was returned in one piece.Visual examination of the lead did not find any anomalies.Electrical testing did not find any indication of conductor fractures or internal shorts.S-curve was measured to be within specification.

• 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: 11090012
• MDR Text Key: 224414107
• Report Number: 2017865-2020-25090
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

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: 06/30/2022
• Device Model Number: 1258T/86
• Device Catalogue Number: 1258T-86
• Device Lot Number: A000083501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 12/30/2020; 01/22/2021
• Supplement Dates FDA Received: 12/31/2020; 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: QUICKFLEX MICRO LV LEAD