MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC ENSITE¿ NAVX¿ SURFACE ELECTRODE KIT; Computer, diagnostic, programmable

Model Number EN0010-100003331

Device Problem Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/12/2024

Event Type  Injury  

Event Description

Following a supraventricular tachycardia-dual procedure, two 1.5 cm second degree electrical burns were noted where the reused surface electrode had been placed on the patient's lower back.A blister was noted two days post procedure which was treated with antibiotic ointment.During the procedure, the patient experienced pain, but did not describe the specific location.At that time, it was discussed with the physician and estimated that the pain may be caused by electrical discharge during ablation operation, which is the cause of a certain degree of pain in most patients.The patient was closely followed with no adverse reactions.There were no performance issues with any devices used in the procedure and no alarms were noted on the generator.

• Brand Name: ENSITE¿ NAVX¿ SURFACE ELECTRODE KIT
• Type of Device: Computer, diagnostic, programmable
• Manufacturer (Section D): ST. JUDE MEDICAL, INC; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19088281
• MDR Text Key: 339925127
• Report Number: 2184149-2024-00059
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: EN0010-100003331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other