MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ISOFLEX OPTIM LEAD; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 1948/58

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559)

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

Event Date 07/28/2023

Event Type  malfunction  

Event Description

It was reported, that the patient presented for an implant procedure.During the procedure, the right ventricular (rv) lead exhibited failure to capture.Failure to sense and high pacing impedance measurement.The lead was not used.And a new lead was implanted.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported events of failure to capture, failure to sense and high pacing impedance were not confirmed.As received, a complete lead was returned.Electrical testing was normal.Visual and x-ray analysis were normal with the exception of procedural damage.

• Brand Name: ISOFLEX OPTIM LEAD
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• 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: 17592044
• MDR Text Key: 321649584
• Report Number: 2017865-2023-37967
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: 05414734502351
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P960030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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 Model Number: 1948/58
• Device Lot Number: P000127512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• 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