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); Therapy Delivered to Incorrect Body Area (1508); Failure to Sense (1559); Device Dislodged or Dislocated (2923)

Patient Problem Discomfort (2330)

Event Date 02/28/2024

Event Type  Injury  

Event Description

It was reported that following an implant procedure, the patient complained of jumping in his chest.The device was interrogated, and it was observed that there was no sensing and no capture on the right atrial (ra) lead.The ra lead was confirmed to have dislodged.The ra lead was explanted and replaced.The patient left in stable condition without any complaints.

• 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: 18918603
• MDR Text Key: 337843605
• Report Number: 2017865-2024-35131
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502320
• UDI-Public: 05414734502320
• 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
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: A000148991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2023
• 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 MRI.; ISOFLEX OPTIM.
• Patient Outcome(s): Required Intervention
• Patient Age: 98 YR
• Patient Sex: Male