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

Catalog Number SD12R-SP05X-000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 04/20/2021

Event Type  Injury  

Event Description

A hemorrhage occured during electrode explant procedure.The patient required additional medical care (unspecified) and was reported as "fine now".

Manufacturer Narrative

No further information was received for this complaint and the device was not returned for analysis.As the product was not returned for evaluation, the root cause was deemed inconclusive.Per the risk assessment, the calculated occurrence matches the occurrence level present in the risk file and the resulting risk level will remain "acceptable".The risk analysis and evaluation file was updated to include "electrode removal results in bleeding" as a potential hazardous situation.No further action is needed at this time.

Event Description

A hemorrhage occured during electrode explant procedure.The patient required additional medical care (unspecified) and was reported as "fine now".

• Brand Name: AD-TECH 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: monique-elise alamina ; 400 west oakview parkway; oak creek, WI 53154 ; 2626341555
• MDR Report Key: 12643030
• MDR Text Key: 276860094
• Report Number: 2183456-2021-00012
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: SD12R-SP05X-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2021
• 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): Required Intervention