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

Catalog Number VARIOUS, SEE H10

Device Problem Signal Artifact/Noise (1036)

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

Event Date 03/25/2022

Event Type  malfunction  

Event Description

Multiple electrodes presented with artifact despite troubleshooting with new headbox.Another diagnostic procedure will need to be performed.

Manufacturer Narrative

13 depth electrodes were involved in the case.Return inspection confirmed signal loss on some or all contacts of each electrode.Quantity, catalog #, udi, mfg.Date 2, sd06r-sp10x-000, (b)(4), 01/04/2022; 1, sd08r-sp05x-000, (b)(4), 01/28/2022; 1, sd08r-sp05x-000, (b)(4), 12/04/2021; 1, sd10r-sp05x-000, (b)(4), 12/16/2021; 5, sd10r-sp05x-000, (b)(4), 02/18/2022; 1, sd12r-sp05x-000, (b)(4), 01/05/2022; 1, sd14r-sp05x-000, (b)(4), 12/06/2021; 1, sd14r-sp05x-000, (b)(4), 01/12/2022.2 subdural electrodes were also involved in the case.Reported under mdr 2183456-2022-00008.

• Brand Name: SPENCER DEPTH ELECTRODES
• 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: 14187234
• MDR Text Key: 291500113
• Report Number: 2183456-2022-00002
• 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: 04/22/2022

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
• Device Catalogue Number: VARIOUS, SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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