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 health professional,study report with the FDA on 2017-04-19 for MAESTRO RECHARGEABLE SYSTEM 2200A-47E manufactured by Enteromedics, Inc..

Event Text Entries

[73254448] Device remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[73254449] Subject participating in the (b)(6) reported a flashing red light on (b)(6) 2017. During a clinic visit on (b)(6) 2017, multiple error code messages were reported including 12 (pulse current below minimum threshold), 3 (high impedence for 60 minutes), and 25 (too many therapy retries). Anterior lead tip to ring and anterior tip to posterior tip impedance readings of >65 kohms were also reported, indicating an open circuit. Therapy could not be re-started.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005025697-2017-00012
MDR Report Key6504794
Report SourceHEALTH PROFESSIONAL,STUDY
Date Received2017-04-19
Date of Report2017-09-29
Date of Event2017-03-27
Date Mfgr Received2017-09-01
Device Manufacturer Date2014-01-24
Date Added to Maude2017-04-19
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 NameANTERIOR LEAD
Product CodePIM
Date Received2017-04-19
Returned To Mfg2017-09-11
Model Number2200A-47E
Catalog Number2200A-47E
Lot NumberCR-01825
Device Expiration Date2017-01-01
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
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 2017-04-19

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