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 Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: (b)(4).During a simplicity rf procedure with the patient on the table and prepped, an error message was noted on ports one and two while connected to the generator.An attempt to switch port 1 and 2 into port 3 were unsuccessful as the errors remained and the procedure was cancelled.

Manufacturer Narrative

One generator to simplicity iii adaptor cable was received for evaluation.The cable successfully attached to the generator with no anomalies noted.The device met specifications for temperature response and no short or open circuits were detected.No visual or functional anomalies were noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported error message and subsequent cancellation 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: 10493642
• MDR Text Key: 205667865
• Report Number: 2182269-2020-00081
• Device Sequence Number: 1
• Product Code: IKD
• UDI-Device Identifier: 05415067028945
• UDI-Public: 05415067028945
• 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
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AC-SI-III
• Device Catalogue Number: AC-SI-III
• Device Lot Number: 7583953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DISPOSABLE SIMPLICITY ELECTRODE; DISPOSABLE SIMPLICITY ELECTRODE
• Patient Outcome(s): Other