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

Model Number 1944/46

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

Patient Problem Discomfort (2330)

Event Date 07/25/2023

Event Type  Injury  

Event Description

It was reported that the patient presented for a follow-up in clinic.It was noted that the right atrial (ra) lead was dislodged which led to minor muscle stimulation.Both a chest x-ray and fluoroscopy was used to verify that the ra lead was dislodged.The ra lead was explanted and replaced.The patient was stable throughout the procedure.

Event Description

Additional information received via a return document indicated the right atrial (ra) lead also had no sensing.

Manufacturer Narrative

The reported events were lead dislodgement, muscle stimulation and failure to sense.The reported event of failure to sense was not confirmed.As received, a complete lead was returned in one piece.Analysis was normal.No anomalies were 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: 17481378
• MDR Text Key: 320610223
• Report Number: 2017865-2023-37798
• Device Sequence Number: 1
• Product Code: NVY
• UDI-Device Identifier: 05414734502313
• UDI-Public: 05414734502313
• 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,Followup,Followup,Followup
• Report Date: 09/12/2023

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: 1944/46
• Device Lot Number: A000139658
• 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: 07/26/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 08/10/2023; 08/24/2023
• Supplement Dates FDA Received: 08/16/2023; 08/23/2023; 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• 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 LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 136 KG