DEPTHALON 2103 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-10 for DEPTHALON 2103 * manufactured by Pmt Corp..

Event Text Entries

[5791136] Stereoelectroencephalography (seeg) leads were placed in early 2015 and removed 9 days later. After removal, an intra-operative x-ray showed several tiny metallic fragments near the skull base. This electrode tip was removed during an already-planned secondary surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number4770804
MDR Report Key4770804
Date Received2015-04-10
Date of Report2015-04-10
Date of Event2015-01-22
Report Date2015-04-10
Date Reported to FDA2015-04-10
Date Reported to Mfgr2015-05-14
Date Added to Maude2015-05-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameDEPTHALON
Generic NameELECTRODE, DEPTH
Product CodeGZL
Date Received2015-04-10
Model Number2103
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Device Sequence No0
Device Event Key0
ManufacturerPMT CORP.
Manufacturer Address1500 PARK RD. CHANHASSEN MN 55317 US 55317

Device Sequence Number: 1

Brand NameDEPTHALON
Generic NameELECTRODE, DEPTH
Product CodeGZL
Date Received2015-04-10
Model Number2102
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerPMT CORP.
Manufacturer Address1500 PARK RD. CHANHASSEN MN 55317 US 55317

Patients

Patient NumberTreatmentOutcomeDate
00 2015-04-10
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