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

Model Number	2002
Medical Device Problem Codes	Device Inoperable (1663); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
During initial implant of maestro rechargeable system, high initial impedance measurements were obtained (765, >65,999, >65,999 ohm).The physician attempted to resolve this by re-inserting the lead connectors in the header of the rechargeable neuroregulator (rnr).The error code "unintended shutdown" was then encountered, losing communication with the rechargeable neuroregulator.Communication could not be re-established with the rnr.After confirming that the issue was not related to external equipment, the rnr was replaced during the same procedure.The procedure was completed successfully with no impact to the patient.

• 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: 5734211
• Report Number: 3005025697-2016-00004
• Device Sequence Number: 16145245
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2016

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: 06/10/2016
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093G29714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2016
• Initial Report FDA Received Date: 06/17/2016
• 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: 47 YR
• Patient Weight: 113