MAESTRO RECHARGEABLE SYSTEM 2200P-47E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-23 for MAESTRO RECHARGEABLE SYSTEM 2200P-47E manufactured by Enteromedics, Inc..

Event Text Entries

[83514062] High impedance of the posterior lead was experienced during an initial implant procedure of the maestro rechargeable system in this patient. After confirming this was not caused by the connection of the lead to the neuroregulator, the posterior lead was replaced during the same procedure. The replacement posterior lead also resulted in high impedance so was also replaced and the procedure completed. Both posterior leads that resulted in high impedance measurements were returned for analysis. This mdr covers investigation of the first posterior lead that was replaced (serial number (b)(4)). Refer to mdr3005025697-2017-00021 for report of the second posterior lead that was replaced during the procedure (serial number (b)(4)).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005025697-2017-00020
MDR Report Key6814585
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-08-23
Date of Report2017-08-23
Date of Event2017-07-31
Date Mfgr Received2017-07-31
Device Manufacturer Date2016-05-26
Date Added to Maude2017-08-23
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 ContactMR. RANDY HOYT
Manufacturer Street2800 PATTON ROAD
Manufacturer CitySAINT PAUL MN 55113
Manufacturer CountryUS
Manufacturer Postal55113
Manufacturer Phone6517892671
Manufacturer G1ENTEROMEDICS, INC.
Manufacturer Street2800 PATTON ROAD
Manufacturer CitySAINT PAUL MN 55113
Manufacturer CountryUS
Manufacturer Postal Code55113
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAESTRO RECHARGEABLE SYSTEM
Generic NamePOSTERIOR LEAD
Product CodePIM
Date Received2017-08-23
Returned To Mfg2017-08-01
Model Number2200P-47E
Catalog Number2200P-47E
Lot NumberC4-12858
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerENTEROMEDICS, INC.
Manufacturer Address2800 PATTON ROAD SAINT PAUL MN 55113 US 55113


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-08-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.