MAUDE Adverse Event Report: MEDTRONIC XOMED INC. APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE; ELECTRODE, NEEDLE

Model Number	8228052
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturer representative that the electrode did not have any signal during a thyroid procedure.There was no troubleshooting done to resolve the device issue and the procedure was completed using a back-up device.There was no patient impact or injury.
Additional Manufacturer Narrative
Analysis found that visually, the yellow c-clip contact was pulled back into the clip body.Per ¿detail a¿ the drawing shows the contact being exposed to the inside diameter of the clip body and the returned sample was 0.05¿ away which indicates an out of specification condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 7994776
• Report Number: 1045254-2018-00530
• Device Sequence Number: 203234
• Product Code: GXZ
• UDI-Device Identifier: 00643169309326
• UDI-Public: 00643169309326
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K083124
• 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,Followup
• Report Date (Section B): 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: 8228052
• Device Catalogue Number: 8228052
• Device Lot Number: 0213738143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1