12 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING AU12D5L25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-11 for 12 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING AU12D5L25 manufactured by Integra Neurosciences Implants S.a..

Event Text Entries

[16085927] The product was used on an epilepsy pt and the depth electrode were implanted. The surgeon explained that he noticed blood in the tubing of the electrode immediately after implantation. The following day, the depth electrode with the blood in the tubing was not operating properly. They were able to localize the pt despite the defective electrode. There was no pt injury and delay in surgery. Additional inf was received from the customer on (b)(6) 2014 with the following. The depth electrodes were implanted and not working properly (with the blood in the tubing) on (b)(6) 2014. The user did not check the depth electrode intraoperatively if it initially worked after it was implanted. Pt age was not provided. The product problem was discovered in the neicu after the electrode was connected to the acquisition unit. The depth electrode "not working properly" was described as the contacts appeared to have flat lines and was not picking up any signal. Blood appeared to be seeping into the inner tubing of the electrode. The cable was switched out but it still did not work. The date of the resection was on (b)(6) 2014. There was no adverse pt consequence due to the defective electrode. The customer reported that had this electrode been working, "we would have had more info localize. This electrode was placed in the area of amygdala. The localization did not suffer as a result of this electrode not working as there were more electrodes in the vicinity. We were able to monitor from other electrodes in the area". The pt had a partial temporal lobectomy and hippocampectomy.
Patient Sequence No: 1, Text Type: D, B5


[16381655] To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612007-2014-00024
MDR Report Key4001822
Report Source05,06
Date Received2014-08-11
Date of Report2014-07-12
Date of Event2014-07-11
Date Mfgr Received2014-07-21
Date Added to Maude2014-08-25
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 FDA0
Event Location0
Manufacturer ContactROWENA BUNUAN
Manufacturer Street315 ENTERPRISE DR
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name12 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING
Generic NameDEPTH ELECTRODES
Product CodeGYC
Date Received2014-08-11
Catalog NumberAU12D5L25
Lot Number185795
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA NEUROSCIENCES IMPLANTS S.A.
Manufacturer AddressSOPHIA ANTIPOLIS F-06921 FR F-06921


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-11

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