SUBDURAL ELECTRODE TS04R-SP10X-0P1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-08 for SUBDURAL ELECTRODE TS04R-SP10X-0P1 manufactured by Ad-tech Medical Instrument Corp..

Event Text Entries

[4429950] Two neurosurgeons 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 patient. A skull x-ray was done after the procedure which confirmed that there were no retained.
Patient Sequence No: 1, Text Type: D, B5


[12027180] These electrodes were removed at bedside. This removal likely was through the burr hole. The electrodes were not removed surgically, as indicated in the electrode directions for use. Percutaneous removal through the burr hole is not in compliance with the device accompanying directions for use. On 05/05/2014, ad-tech medical rec d a copy of the maude event report mw5035491 that (b)(6) submitted to the fda as reportable incident regarding the percutaneous removal of one of ad-tech's strip electrodes, resulting in some contacts (electrode discs) separating from the electrode strips. Dr. Duncan informed ad-tech of the event and confirmed that the separated discs were accounted for and none were retained according to the skull x-ray. The catalog number and expirations date for the impacted subdural electrodes (ts04r-sp10x-0p1, lot 208140493) listed on maude event report (mw5035491) were incorrect. The catalog number is ts04r-sp10x-0p1 instead of ts04r-sp1-x0p1. The manufacturer date for ts04r-sp10x-0p1, lot 208140493 is 11/2012. As subdural electrodes have a two year shelf life. The expiration date is 11/2014. This mdr reflects the correct catalog number and expiration date of the product. Additionally, mw5035491 indicated that the "device was available for evaluation". (b)(6) confirmed: "the product is not available to be shipped back to the manufacturer. "
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183456-2014-00002
MDR Report Key3901860
Report Source05
Date Received2014-05-08
Date of Report2014-05-01
Date of Event2014-03-24
Date Mfgr Received2014-04-10
Device Manufacturer Date2012-11-01
Date Added to Maude2014-07-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street1901 WILLIAM ST.
Manufacturer CityRACINE WI 53404
Manufacturer CountryUS
Manufacturer Postal53404
Manufacturer Phone2626341555
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUBDURAL ELECTRODE
Generic NameSUBDURAL ELECTRODE
Product CodeGYC
Date Received2014-05-08
Catalog NumberTS04R-SP10X-0P1
Lot Number208140493
Device Expiration Date2014-11-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer AddressRACINE WI 53404 US 53404


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-05-08

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