MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. NT1100 & NT2000IX NEUROTHERM GENERATOR TO SIMPLICITY III, ADAPTER CABLE; MEDICAL DEVICE ELECTRICAL CABLE, REUSABLE

Model Number AC-SI-III

Device Problem Melted (1385)

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

Event Date 06/15/2021

Event Type  Injury  

Event Description

During the procedure, a melting / burning smell was noted.Sensory and motor testing were successful.However, when it came to the lesion portion, a melting / burnt smell was noted.While inspecting the system, it was noted that the simplicity cable was melted and the procedure was stopped.

Event Description

Another cable and generator were used to perform the procedure.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported melting/burning smell with the cable remains unknown.

• Brand Name: NT1100 & NT2000IX NEUROTHERM GENERATOR TO SIMPLICITY III, ADAPTER CABLE
• Type of Device: MEDICAL DEVICE ELECTRICAL CABLE, REUSABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 12057218
• MDR Text Key: 258038905
• Report Number: 2182269-2021-00057
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• PMA/PMN Number: K083528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AC-SI-III
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other