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

Model Number 1944/52

Device Problems Failure to Sense (1559); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

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

Event Date 09/08/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: (b)(4).It was reported, that the patient presented in clinic for a follow up.Device interrogation revealed, failure to capture, failure to sense.And dislodgement the atrial (ra) lead, and during the procedure the set screw was unable to be removed from the pacemaker.The physician elected to explant and replace the pacemaker and ra lead.The patient was in stable condition.

Manufacturer Narrative

The reported events were lead dislodgement, inadequate capture and failure to sense.As received, a complete lead was returned in one piece.Electrical, mechanical, and visual analysis was normal with no anomalies found.

• 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: 17866025
• MDR Text Key: 324864750
• Report Number: 2017865-2023-47687
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502320
• UDI-Public: 05414734502320
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

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: P000133787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/10/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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
• Patient Outcome(s): Required Intervention