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 foreign,health professional report with the FDA on 2017-03-01 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Enteromedics, Inc..

Event Text Entries

[68751976] A former subject in the (b)(6) clinical trial (ide g070025; subject (b)(6)) was converted to a maestro rechargeable system on (b)(6) 2015. At the conversion procedure, the original investigational rf neuroregulator was replaced with the commercial model 2002 rechargeable neuroregulator. The anterior and posterior leads, implanted as part of the (b)(6) clinical trial on (b)(6) 2008, were not replaced at the time of conversion to the rechargeable system. On (b)(6) 2015 the site reported that this patient was experiencing low impedance of the anterior lead with related error codes. Therapy was restarted but then the issue returned. Review of radiograph images suggest that this issue was caused by excessive device manipulation by the patient. The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016. Mdrs related to this issues are: mdr3005025697-2017-00005: model 2002 rechargeable neuroregulator, mdr3005025697-2017-00006: model 2200a-47e anterior lead, mdr3005025697-2017-00007: model 2200p-47e posterior lead.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005025697-2017-00006
MDR Report Key6370134
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2017-03-01
Date of Report2017-03-01
Date of Event2016-03-30
Date Mfgr Received2016-04-14
Device Manufacturer Date2007-08-14
Date Added to Maude2017-03-01
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 ContactDR. KATHERINE TWEDEN
Manufacturer Street2800 PATTON ROAD
Manufacturer CitySAINT PAUL MN 55113
Manufacturer CountryUS
Manufacturer Postal55113
Manufacturer Phone6516343209
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 NameANTERIOR LEAD
Product CodePIM
Date Received2017-03-01
Returned To Mfg2017-02-07
Model Number2200A-47E
Catalog Number2200A-47E
Lot NumberC2-09263
Device Expiration Date2008-02-01
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. Hospitalization; 2. Other; 3. Required No Informationntervention 2017-03-01

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