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

Catalog Number SD06R-SP05X-000

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

Mdr 2183456-2019-00017 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 serioius 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.Clinician contacted ad-tech due to repeated occurrences of depth electrode getting caught on bone during explant.After review, an ad-tech clinical specialist was able to recommend an alternative accessory for assisting explant which was reported as successful in a future case.

Event Description

On december 11, 2018 ad-tech received a query from a customer asking for advice on removal technique for depth electrodes, indicating that they had experienced some instances in which the electrode goes in without difficulty, but upon explant the contact appears to get stuck on the edge of the bone.

• Brand Name: DEPTH ELECTRODE
• Type of Device: SPENCER 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: 9553477
• MDR Text Key: 188727935
• Report Number: 2183456-2019-00017
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2020

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 Catalogue Number: SD06R-SP05X-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 01/06/2020
• 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): Other