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

Model Number	2200P-47E
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Material Separation (1562); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591); Material Distortion (2977)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	05/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
A subject participating in the (b)(6) trial (subject id (b)(6)) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011.This subject has had a history of multiple low impedance events related to the implanted posterior lead, resulting in a need to restart therapy.Reported low impedance events for this subject occurred on (b)(6) 2014, (b)(6) 2015, (b)(6) 2016, and a final report of continued impedance issues on (b)(6) 2016.On (b)(6) 2016, it was also reported that this subject is unreliable with charging and attending clinic visits.On april 27, 2017, enteromedics was informed that this subject has decided to have the device explanted.The device was subsequently explanted without incident on (b)(6) 2017.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6589485
• Report Number: 3005025697-2017-00013
• Device Sequence Number: 13711232
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• 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
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physical Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: C4-07865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 08/23/2017
• 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: 39 YR
• Patient Weight: 98