STIMLOC 924256

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-01 for STIMLOC 924256 manufactured by Advanced Uro-solutions, L.l.c..

Event Text Entries

[122191950] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[122191951] Information was received from a healthcare provider about a patient with an implantable neurostimulator (ins) for unknown indications for use. It was reported that during the implant of a lead the burr hole cover cracked. There were no symptoms reported. No further complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012165443-2018-00011
MDR Report Key7922501
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-10-01
Date of Report2018-10-01
Date of Event2018-08-02
Date Mfgr Received2018-09-26
Date Added to Maude2018-10-01
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 FDA3
Event Location3
Manufacturer ContactLISA WOODWARD CLARK
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635263920
Manufacturer G1ADVANCED URO-SOLUTIONS, L.L.C.
Manufacturer Street7842 HICKORY FLAT HIGHWAY SUITE D
Manufacturer CityWOODSTOCK GA 30188
Manufacturer CountryUS
Manufacturer Postal Code30188
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTIMLOC
Generic NameCOVER, BURR HOLE
Product CodeGXR
Date Received2018-10-01
Model Number924256
Catalog Number924256
Lot Number082205818A
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerADVANCED URO-SOLUTIONS, L.L.C.
Manufacturer Address7842 HICKORY FLAT HIGHWAY SUITE D WOODSTOCK GA 30188 US 30188


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-01

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