MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. SD DEPTH ELECTRODE

Model Number SD08R-SP05X-000

Device Problem Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Mdr 2183456-2019-00021 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 occurred, 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 Description

On april 15, 2019, an ad-tech clinical specialist reported that during a case they attended the surgeon encountered an issue after implanting four ad-tech depth electrodes.Upon initial device testing subsequent to implantation it was identified that two of the devices that were labeled as 8 contact depth electrodes were in fact 6 contact depth electrodes.There was no impact to the patient due to this incident.

• Brand Name: SD DEPTH ELECTRODE
• Type of Device: DEPTH ELECTRODE
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek WI 53154
• Manufacturer Contact: pamela stogsdill ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 9654450
• MDR Text Key: 188726722
• Report Number: 2183456-2019-00021
• Device Sequence Number: 1
• Product Code: GZL
• UDI-Device Identifier: 00841823107695
• UDI-Public: (01)00841823107695(17)210101(10)0127219208140699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/31/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: SD08R-SP05X-000
• Device Catalogue Number: SD08R-SP05X-000
• Device Lot Number: 208140699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other