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

Model Number	8228052
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: user report swissmedic - (b)(6), continuation of d10: section d information references the main component of the system.Other device(s) which are used in the event are: product id: nim4cm01, serial/lot #: (b)(6), product id: nim4cpb1, serial/lot #: (b)(6), stimulation probe(lot number: unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the thyroidectomy procedure, the electrode was placed in patient, no signal could be obtained, i.E.The nerve was not stimulated.There was a longer duration of the surgery and timely intervention was not possible.The procedure was completed with a another electrode.There was no patient injury.
Additional Manufacturer Narrative
H3: product analysis found that visually, the c-clip contact was not exposed/flush with the inside diameter of the clip body when returned.There was contamination on the clip body.Electrically, the resistance shall be less than 25 ohms end to end and the actual measurement was 12.6 ohms which was in specification.In the returned condition, there was an out of specification condition that was related to the complaint.H6: previously applied codes fdm b17, fdr c20, fdc d16 are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H6: previously applied fdc d1102 has been corrected to d03.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H6: previously applied fdc d03 has been corrected to d15.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: APS¿ (AUTOMATIC PERIODIC STIMULATION) ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 19391875
• Report Number: 9612501-2024-01278
• Device Sequence Number: 7689589
• Product Code: GXZ
• UDI-Device Identifier: 00763000034085
• UDI-Public: 00763000034085
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2025

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 Model Number: 8228052
• Device Catalogue Number: 8228052
• Device Lot Number: 0227344416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 08/07/2024; 01/03/2025
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/29/2024; 08/07/2024; 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11"
• Patient Age: 44 YR
• Patient Sex: Female