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

Model Number 1944/52

Device Problems High impedance (1291); Use of Device Problem (1670); Device Sensing Problem (2917)

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

Event Date 12/25/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, the right atrial (ra) lead was unable to be implanted due to unspecified parameters and stability issues.The lead was not used, and a new lead was implanted.The patient was stable throughout the procedure.

Event Description

New information received notes that the ra lead also exhibited high pacing impedance and sensing measurements issue.

Manufacturer Narrative

The reported events were ¿the lead was not stable in all positioning¿, high pacing impedance and p-wave amp variation.As received, a complete lead was returned with all tines intact.The reported events of high pacing impedance and p-wave amp variation were not confirmed.Electrical testing and visual inspection of the lead did were normal.

• 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: 18499891
• MDR Text Key: 332917300
• Report Number: 2017865-2024-00991
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

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: 1944/52
• Device Lot Number: P000162785
• 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: 12/25/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/18/2024; 02/21/2024
• Supplement Dates FDA Received: 01/18/2024; 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2023
• 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