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

Catalog Number UNKNOWN

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2001

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed within 30 days of ad-tech becoming aware of the retained depth collar which occured approximately 20 years ago.Physician was not able to provide specific user facility (potentially (b)(6) in (b)(6)), electrode manufacturer (ad-tech or pmt), catalog number, or lot information for this event.There has been no patient harm reported with the retained contact.The implant date is approximate, based on physician notes of (b)(6) 2001.The 510(k) number referenced in this report is that which ad-tech depth electrodes were marketed under in 2001.The current 510(k) number for ad-tech depth electrodes is k163355.

Event Description

On (b)(6) 2021, ad-tech's customer support was contacted inquiring about the contact material of depth electrodes.The physician communicated that they had a patient with a retained electrode contact within the brain from early 2001, and wanted to know if the contact was made of stainless steel or platinum at that time.They also stated that they were not certain if it was an ad-tech or pmt electrode.As there was no complaint or mdr record from that time period, this mdr is being filed as a conservative measure.

• 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: 13001693
• MDR Text Key: 289974469
• Report Number: 2183456-2021-00014
• Device Sequence Number: 1
• Product Code: GZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964644
• 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: 12/13/2021

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/14/2021
• 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