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); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

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

Event Date 07/31/2023

Event Type  Injury  

Event Description

It was reported that the patient presented one day post implant with loss of capture and failure to sense exhibited by the right ventricular lead.It was confirmed that the lead had dislodged.The lead was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported events were lead dislodgement, loss of capture and failure to sense.As received, a complete lead was returned in one piece with all four tines were found to be intact and undamaged.The reported events of loss of capture and sensing were not confirmed.Electrical tests did not find any indication of conductor fractures or internal shorts.Visual and x-ray inspections of the lead did not find any anomalies.

• 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: 17587050
• MDR Text Key: 321569924
• Report Number: 2017865-2023-38899
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: 05414734502351
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P960030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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: 1948/58
• Device Lot Number: A000141348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 08/28/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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
• Treatment: ASSURITY; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Sex: Male