MAUDE Adverse Event Report: AD-TECH MED INSTRUMENT CORP SUBDURAL ELECTRODE

Model Number TS06RSP10X000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/28/2014

Event Type  malfunction  

Event Description

Two surgeons removed 8 strip electrodes at bedside and noted that in 2 of the 8 strip electrodes some electrode discs separated from the electrode strips as they were being pulled through the skin.This is an unexpected occurrence.The other 6 electrodes were removed in the usual fashion without any problems and were intact.The separated discs were accounted for and there was no injury to the pt.A skull x-ray was done after the procedure which confirmed that there were no retained electrode parts.Diagnosis or reason for use: implanted for eeg monitoring.

• Brand Name: SUBDURAL ELECTRODE
• Type of Device: SUBDURAL ELECTRODE
• Manufacturer (Section D): AD-TECH MED INSTRUMENT CORP; racine WI 53401
• MDR Report Key: 3736502
• MDR Text Key: 4276831
• Report Number: MW5035532
• Device Sequence Number: 2
• Product Code: GYC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: TS06RSP10X000
• Device Lot Number: 208140535
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 51