MAUDE Adverse Event Report: ENTEROMEDICS, INC. MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR

Model Number	2002
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device still implanted; not returned.
Event or Problem Description
This recharge clinical trial subject was implanted with the maestro rechargeable system on (b)(6) 2011.This subject has experienced several magnet swipe deactivations of the implanted rechargeable neuroregulator, that were initially reported on (b)(6) 2016.On (b)(6) 2016 additional information was received indicating multiple additional unanticipated deactivations of the rnr on (b)(6) 2016 with no associated magnet deactivation code.At last report, this subject is currently receiving therapy from the implanted device.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6237405
• Report Number: 3005025697-2017-00002
• Device Sequence Number: 10857243
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/29/2012
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093511911A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EZETROL 10 MG; MULTIVITAMIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 101