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 03/26/2024

Event Type  Injury  

Manufacturer Narrative

E1: reporter phone number: (b)(6).Unique device identifier (udi #): the udi is unknown because the lot number was not provided.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.

Event Description

Related manufacturer reference number: 3005334138-2024-00142 it was reported that during a procedure a message was received stating the electrode has been changed.As such, the treatment was stopped, and the patient was changed to medication treatment.Reportedly, there were no adverse consequence to the patient.A replacement adapter and same needle were used but the issue persisted.However, when troubleshooting with a representative¿s adapter cable, the issue was resolved.

• 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: 19121554
• MDR Text Key: 340339171
• Report Number: 2182269-2024-00009
• Device Sequence Number: 1
• Product Code: IKD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083528
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DAC-NT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other