PMT SEEG DEPTHALON DEPTH ELECTRODE UNK

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 2015-06-18 for PMT SEEG DEPTHALON DEPTH ELECTRODE UNK manufactured by Pmt Corporation.

Event Text Entries

[16899909] Pmt corporation received a medwatch on (b)(6) 2015 regarding a patient that had a metal fragment left behind after removal of depth electrode. Here is the original narrative from the medwatch received. "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 based. This electrode tip was removed during an already planned secondary surgery. "
Patient Sequence No: 1, Text Type: D, B5


[17036643] Pmt reviewed all information that was received from the user. The direct cause of the event is unable to be determined since the device and accompanying components were not returned for investigation/evaluation. The potential cause could be that the electrode tip somehow got lodged at the bottom of the anchor bolt when the surgeon was removing the electrode, causing the distal tip to break off and be left behind. However without evaluating the components, this is speculation. The user facility had no information regarding model numbers or lot numbers of the product reported.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2182979-2015-00001
MDR Report Key4863241
Report Source05
Date Received2015-06-18
Date of Report2015-06-15
Date of Event2015-01-22
Date Mfgr Received2015-05-18
Date Added to Maude2015-07-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKIM SCHMELZER
Manufacturer Street1500 PARK RD. P.O. OX 610
Manufacturer CityCHANHASSEN MN 55317
Manufacturer CountryUS
Manufacturer Postal55317
Manufacturer Phone9524700866
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePMT SEEG DEPTHALON DEPTH ELECTRODE
Product CodeGZL
Date Received2015-06-18
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPMT CORPORATION
Manufacturer AddressCHANHASSEN MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-06-18

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