SUBDURAL STRIP ELECTRODES REFER TO H.10 FOR PRODUCTS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-09 for SUBDURAL STRIP ELECTRODES REFER TO H.10 FOR PRODUCTS manufactured by Ad-tech Medical Instrument Corp..

Event Text Entries

[90222878] As stated in the describe event section, each electrode was pulled to deliver it through the exiting stab incision made during the initial surgery. The following electrodes were used in the surgery: catalog number: ts04r-sp10x-000, lot #: 208140624, qty: 4, exp. Date: 2018-10-01, (b)(4); ts04r-sp10x-000, 208140593, 1, 2017/08, n/a (this lot was manufactured prior to the implementation of udi); ts04r-sp10x-000, 208140623, 1, 2018/09, n/a (this lot was manufactured prior to the implementation of udi). Prior to this complaint, ad-tech had received several complaints of similar nature. Due to the number of complaints received, a corrective action/preventive action (capa) investigation was initiated to address this issue in may 2014. The probable root cause for this issue (disc dislodgement) was found to be due to percutaneous removal of the electrodes by the end user; ad-tech's directions for use (dfu) specifically states that ad-tech's subdural strip electrodes be removed surgically. As a correction to the capa, the following warning statement was incorporated into ad-tech's dfu in june 2014, "warning: percutaneous removal may result in the separation of materials, requiring surgical intervention to retrieve the electrode and contacts. " a memo was sent to all ad-tech neurosurgeon customers informing them of the addition to the dfu in june 2014. It was confirmed that the hospital acknowledged notification of this addition on 7/14/2014. On 10/9/2017, ad-tech sent the hospital an email reiterating the importance of surgically removing the electrodes and not percutaneously removing them. The directions for use (dfu) was also attached to the email showing the warning.
Patient Sequence No: 1, Text Type: N, H10


[90222879] On september 6, 2017 ad-tech medical received an email from a customer stating that six (6) 1x4 subdural strips were implanted in a patient on (b)(6) 2017. Upon removal, several of the electrodes broke off. The patient was returned to the or to attempt to remove the electrodes. Ad-tech follow-up with the customer requesting information on how the electrodes were removed. It was stated that "using gentle pressure, each electrode was pulled to deliver it through the exiting stab incision made during the initial surgery. Two (2) of the electrodes on the left, and one on the right, did not deliver through the incisions, resulting in retained hardware. " the patient remains neurologically intact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183456-2017-00008
MDR Report Key6932054
Date Received2017-10-09
Date of Report2017-10-06
Date of Event2017-08-28
Date Mfgr Received2017-09-06
Date Added to Maude2017-10-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. KATHLEEN BARLOW
Manufacturer Street1901 WILLIAM STREET
Manufacturer CityRACINE WI 53404
Manufacturer CountryUS
Manufacturer Postal53404
Manufacturer Phone2626341555
Manufacturer G1AD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Street1901 WILLIAM STREET
Manufacturer CityRACINE WI 53404
Manufacturer CountryUS
Manufacturer Postal Code53404
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSUBDURAL STRIP ELECTRODES
Generic NameSUBDURAL STRIP ELECTRODES
Product CodeGYC
Date Received2017-10-09
Catalog NumberREFER TO H.10 FOR PRODUCTS
Lot NumberREFER TO H.10 FOR LOTS
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Address1901 WILLIAM STREET RACINE WI 53404 US 53404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-10-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.