MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. FREMAP ELECTRODE; SURGICAL NERVE STIMULATOR/LOCATOR

Catalog Number	DCNE-01X
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2183456-2019-00018 has been filed past the 30-day timeframe.Through the 2019 fda inspection, it was identified that while ad-tech was evaluating reportability for actual events in which death or serious injury had occured, ad-tech had failed to submit events in which a malfunction was reported and could result in a serious injury if the event were to recur.As part of the investigation, a two (2) year retrospective review of complaints was performed to determine which complaints required submission of an mdr.
Event or Problem Description
On december 14, 2018, ad-tech received a customer complaint indicating that before implantation it was noticed that a platinum disk was coming loose from the silicone housing of an electrode.The electrode was not placed and there was no injury to the patient.

• Brand Name: FREMAP ELECTRODE
• Common Device Name: SURGICAL NERVE STIMULATOR/LOCATOR
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• MDR Report Key: 9644402
• Report Number: 2183456-2019-00018
• Device Sequence Number: 1367791
• Product Code: ETN
• UDI-Device Identifier: 90841823108480
• UDI-Public: (01)90841823108480(17)190801(10)0109203208140650
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: 08/01/2019
• Device Catalogue Number: DCNE-01X
• Device Lot Number: 208140650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/29/2020
• 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