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

Model Number	2200A-47E
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Subject participating in the (b)(6).This subject was implanted with the maestro rechargeable system on (b)(6) 2011.During a clinic visit on (b)(6) 2016, error codes were received for low impedance of the anterior lead and too many therapy retries.Alarms were cleared and therapy resumed.Therapy was again interrupted from (b)(6) 2016.During a clinic visit on (b)(6) 2016, the same error codes as occured on (b)(6) 2016 were cleared and therapy was resumed.On (b)(6) 2017 an anterior tip to anterior ring short was experienced again.The device was explanted on (b)(6) 2017.Extreme scarring and adhesions were noted at explant.However, the entire device was able to be explanted.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: ANTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6316569
• Report Number: 3005025697-2017-00004
• Device Sequence Number: 11157329
• Product Code: PIM
• UDI-Device Identifier: 00857334004286
• UDI-Public: 00857334004286
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/01/2014
• Device Model Number: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Device Lot Number: C4-07862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/09/2017
• Supplement 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 109