MAUDE Adverse Event Report: AD-TECH MEDICAL INSTRUMENT CORP. SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

Device Problem Off-Label Use (1494)

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

Event Type  Injury  

Manufacturer Narrative

As stated in the description, on (b)(6) 2019, it was brought to ad-tech's attention by an fda inspector that their clinical specialists (sales department) may be sending customers mri information for subdural and depth electrodes upon request.Qa/regulatory was unaware of this and upon questioning, was able to confirm that the clinical specialists were in fact sending this information.According to the directions for use (dfus) for subdural and depth electrodes, it is stated that the electrodes have not been evaluated for safety and compatibility in the mr environment.They have not been tested for heating, migration, or image artifact in the mr environment.The safety of the electrodes in the mr environment is unknown.This affects all ad-tech subdurals, depths, and anchor bolts: subdural product code: gyc subdural 510(k): k053363.Depth product code: gzl depth 510(k): k163355.Anchor bolt product code: gzl anchor bolt 510(k): k181544.No adverse events have been reported related to this supplementary labeling.

Event Description

On (b)(6) 2019, it was brought to ad-tech's attention by an fda inspector that their clinical specialists (sales department) may be sending customers mri information for subdural and depth electrodes upon request.Qa/regulatory was unaware of this and upon questioning, was able to confirm that the clinical specialists were in fact sending this information.According to the directions for use (dfus) for subdural and depth electrodes, it is stated that the electrodes have not been evaluated for safety and compatibility in the mr environment.They have not been tested for heating, migration, or image artifact in the mr environment.The safety of the electrodes in the mr environment is unknown.

• Brand Name: SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
• Type of Device: SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
• Manufacturer (Section D): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek 53154
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek 53154
• Manufacturer Contact: kathleen barlow ; 400 west oakview parkway; oak creek 53154 ; 2626341555
• MDR Report Key: 8701820
• MDR Text Key: 148147855
• Report Number: 2183456-2019-00004
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/14/2019

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/14/2019
• 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: Unknown
• Patient Sequence Number: 1