AQUAMANTYS GENERATOR 40-402-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-08 for AQUAMANTYS GENERATOR 40-402-1 manufactured by Medtronic Advanced Energy, Llc.

Event Text Entries

[16780510] After a micro discectomy spine case, where the aquamantys system was utilized, it was reported that a patient had a loss of feeling in his one leg below the knee. Patient was taken back into surgery two days later for a decompression procedure. At the time of the reported incident the patient did not have feeling in his leg back yet, but the surgeon stated that he anticipates the sensory and motor function to return to normal over 1 to 3 months.
Patient Sequence No: 1, Text Type: D, B5


[17003240] Product event # (b)(4) evaluation method/result/conclusion: generator still in use; therefore, analysis unable to be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226420-2014-00063
MDR Report Key3994159
Report Source06,07
Date Received2014-08-08
Date of Report2014-07-11
Date of Event2014-07-08
Date Mfgr Received2014-07-11
Date Added to Maude2014-08-11
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 FDA0
Event Location0
Manufacturer ContactKAYLEE BOISVERT
Manufacturer Street180 INTERNATIONAL DRIVE
Manufacturer CityPORTSMOUTH NH 03801
Manufacturer CountryUS
Manufacturer Postal03801
Manufacturer Phone6038426234
Manufacturer G1MEDTRONIC ADVANCED ENERGY, LLC
Manufacturer Street180 INTERNATIONAL DRIVE
Manufacturer CityPORTSMOUTH NH 03801
Manufacturer CountryUS
Manufacturer Postal Code03801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUAMANTYS GENERATOR
Generic NameGENERATOR,ELECTROSURGICAL,COAGULATION,CANCER
Product CodeMUL
Date Received2014-08-08
Model Number40-402-1
Catalog Number40-402-1
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC ADVANCED ENERGY, LLC
Manufacturer Address180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-08

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