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

Model Number 1948/58

Device Problem Use of Device Problem (1670)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the right ventricle (rv) lead was unable to be implanted.The rv lead was not used.The physician elected to use another rv lead and completed the procedure.The patient was in stable condition.

Manufacturer Narrative

The reported event was ¿lead was not able to fix at rv apex¿.A complete lead was returned in one piece.Electrical testing, visual inspection and x-ray examination of the lead were normal with no anomalies found.

Manufacturer Narrative

Correction: the correct date returned to manufacturer should have been may 16, 2024, rather than may 18, 2024.

• 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: 19017372
• MDR Text Key: 339086631
• Report Number: 2017865-2024-37428
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502351
• UDI-Public: (01)05414734502351(10)P000161389(17)251231
• 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,Followup
• Report Date: 05/31/2024

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: 1948/58
• Device Lot Number: P000161389
• 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: 03/15/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/30/2024; Not provided; Not provided
• Supplement Dates FDA Received: 04/30/2024; 05/28/2024; 05/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2023
• 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