MAESTRO RECHARGEABLE SYSTEM 2200A-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 2017-12-14 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Reshape Lifesciences.

Event Text Entries

[94818608] This patient was implanted with the maestro rechargeable system on (b)(6) 2016. On (b)(6) 2016, the patient visited the emergency room and was treated for apparent infection with iv antibiotics. The patient was not admitted to the hospital, but was sent home the same day on oral antibiotics (bactrium). Patient was on bactrium from (b)(6) 2016 through (b)(6) 2017. At a clinic visit on (b)(6) 2017, the incision was reported to appear as if it was healing normally. No further reports have been received for this patient. This mdr covers investigation of the anterior lead. Refer to mdr 3005025697-2017-00024 for report of the rechargeable neuroregulator and mdr 3005025697-2017-00026 for report of the posterior lead.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005025697-2017-00025
MDR Report Key7116896
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-12-14
Date of Report2017-12-14
Date of Event2016-12-13
Date Mfgr Received2017-02-23
Device Manufacturer Date2015-06-08
Date Added to Maude2017-12-14
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 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 NameANTERIOR LEAD
Product CodePIM
Date Received2017-12-14
Model Number2200A-47E
Catalog Number2200A-47E
Lot NumberCR-01922
Device Expiration Date2018-06-01
OperatorPHYSICIAN
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRESHAPE LIFESCIENCES
Manufacturer Address2800 PATTON ROAD SAINT PAUL MN 55113 US 55113


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-12-14

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