MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. NEUROTHERM¿ ADAPTOR CABLE NT GENERATOR TO DISPOSABLE; MEDICAL DEVICE ELECTRICAL CABLE, SINGLE USE

Model Number	DACUK-NT
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported low impedance and a "burning smell" could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported impedance issue, burning smell and subsequent procedure cancellation could not be conclusively determined.
Event or Problem Description
During a bipolar palisade ablation procedure, the impedance was low and the generator emitted a burning smell so the procedure was cancelled.Following the cancellation, further troubleshooting determined the issue was due to the adapter cable.A new cable was used in all ports and the impedance displayed as intended and no burning smell was noted.There were no adverse consequences to the patient due to the cancellation and the procedure was rescheduled for a later date.

• Brand Name: NEUROTHERM¿ ADAPTOR CABLE NT GENERATOR TO DISPOSABLE
• Common Device Name: MEDICAL DEVICE ELECTRICAL CABLE, SINGLE USE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• MDR Report Key: 8477692
• Report Number: 2182269-2019-00035
• Device Sequence Number: 19277878
• Product Code: GEI
• UDI-Device Identifier: 05415067021335
• UDI-Public: 05415067021335
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K083528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: DACUK-NT
• Device Lot Number: 5770101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other