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

Model Number 1944/52

Device Problems Failure to Capture (1081); Fracture (1260); Failure to Sense (1559)

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

Event Date 07/20/2023

Event Type  Injury  

Event Description

It was reported, during in clinic follow up.That the atrial lead exhibited loss of capture and loss of sensing.Fluoroscopy revealed, that the lead was fractured.The lead was explanted and successfully replaced.The patient was stable and asymptomatic.

Manufacturer Narrative

The reported events of failure to capture, failure to sense and lead fracture were not confirmed.As received, a complete lead with stylet inserted was returned in one piece.Electrical testing and x-ray examination did not find any indication of conductor fractures or internal shorts.Visual inspection of the lead did not find any anomalies except for the damages found consistent with procedural damage.All tines were intact and undamaged.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 17450502
• MDR Text Key: 320303204
• Report Number: 2017865-2023-37472
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502320
• UDI-Public: 05414734502320
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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,Followup
• Report Date: 10/18/2023

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: 1944/52
• Device Lot Number: P000151061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 10/18/2023
• Supplement Dates FDA Received: 09/07/2023; 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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
• Patient Outcome(s): Required Intervention