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

Model Number	2002
Medical Device Problem Codes	Device Inoperable (1663); Use of Device Problem (1670); Low impedance (2285); Device Displays Incorrect Message (2591); Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
A former subject in the empower clinical trial ((b)(4); subject id (b)(6)) was originally converted to a maestro rechargeable system on (b)(6) 2015.The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016 (refer to mdr3005025697-2017-00005 through mdr3005025697-2017-00007 for details on original rechargeable system removal due to excessive manipulation).On (b)(6) 2016, the site reported that alerts for low impedance were experienced at follow-up, noting that the ring electrodes were placed quite close together at implant.On (b)(6) 2016, it was reported that low impedance measurements were again experienced.Radiograph review suggested that the ring electrodes were in very close proximity to each other with twisting of the leads near the neuroregulator.The replacement system was explanted on (b)(6) 2016.Mdrs related to this issue are: mdr3005025697-2017-00008: model 2002 rechargeable neuroregulator.Mdr3005025697-2017-00009: model 2200a-47e anterior lead.Mdr3005025697-2017-00010: model 2200p-47e posterior lead.

• 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: 6370106
• Report Number: 3005025697-2017-00008
• Device Sequence Number: 19122637
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 12/01/2016
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093513215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 03/01/2017
• 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: BUSCOPAN; IBUPROFEN; OXYCODONE; PARACETAMOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 122