MAESTRO RECHARGEABLE SYSTEM 2002

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 2018-01-09 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Lifesciences.

Event Text Entries

[97381599] While interrogating the rechargeable neuroregulator device prior to implant, a red status led was displayed when attempting to check the battery status. The error condition was checked which indicated a magnet swipe shutdown had occurred. The field clinician engineer decided not use this device and proceeded with a back up unit.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005025697-2018-00001
MDR Report Key7176223
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-01-09
Date of Report2018-01-09
Date of Event2016-12-09
Date Mfgr Received2016-12-09
Device Manufacturer Date2015-05-13
Date Added to Maude2018-01-09
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 Phone6517982671
Manufacturer G1RESHAPE LIFESCIENCES
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 NameRECHARGEABLE NEUROREGULATOR
Product CodePIM
Date Received2018-01-09
Returned To Mfg2016-12-14
Model Number2002
Catalog Number2002
Device Expiration Date2016-12-10
OperatorMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRESHAPE LIFESCIENCES
Manufacturer Address2800 PATTON ROAD SAINT PAUL MN 55113 US 55113


Patients

Patient NumberTreatmentOutcomeDate
10 2018-01-09

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