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

Model Number	2200P-47E
Medical Device Problem Codes	Bent (1059); Electrical /Electronic Property Problem (1198); Material Separation (1562); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	09/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
(b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.
Event or Problem Description
An (b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.Supplement 001: this subject underwent successful explant of the complete maestro rechargeable system on (b)(6) 2017.No adverse events were reported with the explant procedure.No explanted components have been received by enteromedics.
Event or Problem Description
An (b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.Supplement 001: this subject underwent successful explant of the complete maestro rechargeable system on (b)(6) 2017.No adverse events were reported with the explant procedure.No explanted components have been received by enteromedics.Supplement 002: explanted device received for analysis on november 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: 6000063
• Report Number: 3005025697-2016-00009
• Device Sequence Number: 681474
• 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: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2017

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: 09/01/2014
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: 11716-555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: 08/10/2017; 11/06/2017
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 08/16/2017; 12/01/2017
• 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: CODRAL 1 TAB PRN; ESOMEPRAZOLE 40 MG; FISH OIL 3 TABS; PARACETOMOL 1000 MG PRN; PSEUDOEPHEDRINE HYDROCHLORIDE 20 MG PRN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 104