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

Catalog Number SD08R-AP58X-000

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

As stated in the event description, on (b)(6) 2020, ad-tech's sales manager was notified via email, of an issue from one of their distributors.The distributor had stated that they had received a complaint from a customer stating that one (1) 8-contact depth electrode ".Had ended with blood +/- cerebral spinal fluid (csf) entering the electrode shaft." a follow up email was sent to the distributor on march 10, 2020 requesting additional information, including if there was any impact to patient safety.Ad- tech is currently awaiting a response.According to the customer, they were concerned about this as it presents a potential infection risk.Ad-tech performed a preliminary risk assessment of the issue.The event identified an inadequate hermetic seal of the brain end contacts and therefore, the most applicable harm was deemed, "biological - adverse or allergic reaction".

Event Description

On (b)(6) 2020, ad-tech's sales manager was notified via email, of an issue from one of their distributors.The distributor had stated that they had received a complaint from a customer stating that one (1) 8-contact depth electrode ".Had ended with blood +/- cerebral spinal fluid (csf) entering the electrode shaft." a follow up email was sent to the distributor on march 10, 2020 requesting additonal information, including if there was any impact to patient safety.Ad-tech is currently awaiting a response.

• Brand Name: DEPTH ELECTRODE
• Type of Device: SPENCER DEPTH ELECTRODE
• Manufacturer (Section G): AD-TECH MEDICAL INSTRUMENT CORP.; 400 west oakview parkway; oak creek, wi
• Manufacturer Contact: kathleen barlow ; 400 west oakview parkway; oak creek, wi ; 6341555301
• MDR Report Key: 9944230
• MDR Text Key: 187558143
• Report Number: 2183456-2020-00021
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163355
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/09/2020

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: No Information
• Device Catalogue Number: SD08R-AP58X-000
• Device Lot Number: 717718719
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1