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

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019, ad-tech was informed that depth electrodes were unable to be used due to bent stylets.The alleged deficiency was found before implantation and other electrodes were used.There was no impact to the patient.No product was returned for analysis and no lot information was provided by the complainant.

Manufacturer Narrative

At the initial assessment of this complaint, it was determined that this was not a reportable event as there was no patient impact and the risk of patient harm was thought to be remote at the time.However, during the 2022 fda inspection, it was suggested ad-tech re-evaluate the reportability for this complaint.Fda advised ad-tech that as later complaints for "bent electrode" were considered reportable due to risk file interpretation based on clinician input, earlier complaints should have also be reported.As documented within the complaint, there was no impact to the patient as a result of this issue.Per our risk assessment, the risk remains alap (as low as possible) and matches that of the risk file.No updates to the risk file are needed at this time.The bent electrodes were not returned to ad-tech, therefore, no further evaluation could be performed.The cause was deemed inconclusive as very little information was obtained from the complainant.This complaint was closed and the trend code is being monitored for future occurrence.

• 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: 14316542
• MDR Text Key: 291499483
• Report Number: 2183456-2022-00011
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 05/07/2022
• 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