MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-MINNETONKA) NEUROTHERM¿ GENERATOR TO DISPOSABLE US ELECTRODE, ADAPTER CABLE; CABLE, ELECTRODE

Model Number DAC-NT

Device Problem Connection Problem (2900)

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

Event Date 02/09/2024

Event Type  Injury  

Event Description

Related manufacturer report number: 2184149-2024-00042.It was reported that a procedure was abandoned due to the facility reporting receiving error messages when the grounding pad was connected.Other grounding pads available at the time also displayed error messages and the procedure was abandoned.The generator and adapter were replaced, resolving the issue.The patient is reported to be stable.

Manufacturer Narrative

Correction: report type corrected to serious injury.Correction e1: initial reporter name was missing.Correction e3: occupation changed to physician.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: NEUROTHERM¿ GENERATOR TO DISPOSABLE US ELECTRODE, ADAPTER CABLE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL (CVD-MINNETONKA); 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer (Section G): ST. JUDE MEDICAL (CVD-MINNETONKA); 14901 deveau place; minnetonka MN 55345 2126
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18813069
• MDR Text Key: 336616667
• Report Number: 2182269-2024-00005
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083528
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DAC-NT
• Device Lot Number: 8747337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1