FDA.reportPublic FDA data

MAUDE MDR 6932054

MDR report key
6932054
Report number
2183456-2017-00008
Event key
0
Event type
3
Date of event
2017-08-28
Date received
2017-10-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. KATHLEEN BARLOW
Address
1901 WILLIAM STREET RACINE WI 53404 US
Phone
262-262-2626
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUBDURAL STRIP ELECTRODESSUBDURAL STRIP ELECTRODESAD-TECH MEDICAL INSTRUMENT CORP.GYCREFER TO H.10 FOR PRODUCTSREFER TO H.10 FOR LOTSR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-0901. O

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.