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

Catalog Number SD12R-SP05X-000

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2021

Event Type  malfunction  

Manufacturer Narrative

User facility report# (b)(4).User facility was not able to provide specific lot information for this event.Two possibilities exist and are being investigated, though only one electrode was involved: (b)(4) (manufactured 11/24/2020) and (b)(4) (manufactured 10/05/2020).

Event Description

On august 15, 2021, ad-tech's clinical specialist was notified via email of an issue from one of their customers.The physician stated that they had discovered after monitoring, that two electrode contacts had been retained within the brain.The customer filed a medwatch report on august 18, 2021 under uf report# (b)(4).Within the report, it was stated that the "electrode contacts were not removed as risk felt to outweigh benefit."; to date, there has been no report of patient harm.

Manufacturer Narrative

User facility report# (b)(4).User facility was not able to provide specific lot information for this event.Two possibilities exist and are being investigated, though only one electrode was involved: (b)(4) (manufactured 11/24/2020) and (b)(4).Updated 5/25/2022.It was reported by the user facility that all of the explanted electrodes appeared to be intact.Further communication indicated that during implant one electrode had a stylet issue and was replaced, but there was no confirmation that the replaced electrode was related to the remnant.Root cause of the electrode break was not able to be determined.Per the risk assessment, the calculated occurence matches the applicable risk file and the risk level remains "acceptable" and no risk updates are needed at this time.

Event Description

On august 15, 2021, ad-tech's clinical specialist was notified via email of an issue from one of their customers.The physician stated that they had discovered after monitoring, that two electrode contacts had been retained within the brain.The customer filed a medwatch report on august 18, 2021 under uf report# 0039-0111-2021-0010.Within the report, it was stated that the "electrode contacts were not removed as risk felt to outweigh benefit."; to date, there has been no report of patient harm.

• Brand Name: 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: 12471357
• MDR Text Key: 273888296
• Report Number: 2183456-2021-00009
• Device Sequence Number: 1
• Product Code: GZL
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

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 Catalogue Number: SD12R-SP05X-000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 08/15/2021
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Other
• Patient Age: 49 YR
• Patient Sex: Female