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

Model Number	2200A-47E
Medical Device Problem Codes	Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
Subject participating in the (b)(6) reported a flashing red light on (b)(6) 2017.During a clinic visit on (b)(6) 2017, multiple error code messages were reported including 12 (pulse current below minimum threshold), 3 (high impedence for 60 minutes), and 25 (too many therapy retries).Anterior lead tip to ring and anterior tip to posterior tip impedance readings of >65 kohms were also reported, indicating an open circuit.Therapy could not be re-started.
Event or Problem Description
Subject participating in the (b)(6) clinical trial (b)(4) reported a flashing red light on (b)(6) 2017.During a clinic visit on (b)(6) 2017, multiple error code messages were reported including 12 (pulse current below minimum threshold), 3 (high impedenace for 60 minutes), and 25 (too many therapy retries).Anterior lead tip to ring and anterior tip to posterior tip impedance readings of >65 kohms were also reported, indicating an open circuit.Therapy could not be re-started.Supplement 001: the maestro rechargeable system was explanted without incident on (b)(6) 2017.

• 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: 6504794
• Report Number: 3005025697-2017-00012
• Device Sequence Number: 14734
• 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: 2015
• 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): 09/29/2017

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: 01/01/2017
• Device Model Number: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Device Lot Number: CR-01825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: ALEVE (PRN); ATORVASTATIN 10 MG; COSTCO SLEEP AID (PRN); FLUOXETINE 20 MG; HALOBETASOL PROPRIONATE .05% (PRN); METHYLPHENIDATE HCL (PRN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Weight: 105