SPENCER DEPTH ELECTRODE STEREO SD08R-SP10X-000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for SPENCER DEPTH ELECTRODE STEREO SD08R-SP10X-000 manufactured by Ad-tech Medical Instrument Corp..

Event Text Entries

[128396704] On (b)(6) 2018, pt underwent craniotomy in the operating room for depth electrodes placement to allow invasive eeg monitoring on inpatient unit. On (b)(6) 2018 during planned electrode removal at bedside, the distal end of the 8 contact depth electrode was retained. One of the depth electrodes has a shear in it just past the first contact.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5081552
MDR Report Key8099846
Date Received2018-11-21
Date of Report2018-11-13
Date of Event2018-11-01
Date Added to Maude2018-11-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameSPENCER DEPTH ELECTRODE STEREO
Generic NameEEG ELECTRODES / ELECTRODE DEPTH
Product CodeGZL
Date Received2018-11-21
Model NumberSD08R-SP10X-000
Catalog NumberSD08R-SP10X-000
Lot Number0123457208140688
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerAD-TECH MEDICAL INSTRUMENT CORP.
Manufacturer Address400 WEST OAKVIEW PKWY OAK CREEK WI 53154 US 53154

Device Sequence Number: 1

Brand NameSPENCER DEPTH ELECTRODE STEREO
Generic NameEEG ELECTRODES / ELECTRODE DEPTH
Product CodeGZL
Date Received2018-11-21
Model NumberSD08R-SP10X-000
Catalog NumberSD08R-SP10X-000
Lot Number0123457208140688
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAD-TECH MEDICAL
Manufacturer Address400 WEST OAKVIEW PKWY OAK CREEK WI 53154 US 53154


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-11-21

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