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

Model Number	2002
Medical Device Problem Codes	Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271); Patient Problem/Medical Problem (2688)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was seen in clinic approximately 2 weeks after implant of the maestro rechargeable system.Upon initial device interrogation, the alarm code indicating the implanted device had been shut down due to a magnet swipe.The patient did not recall being near any strong magnets.Therapy was restarted.During the week of (b)(6) 2016, it was again reported that the device was again shut down with alarm code indicating this was due to a magnet swipe.Therapy was again restarted without adverse impact to the patient.
Additional Manufacturer Narrative
Device remains implanted; not returned.
Event or Problem Description
Patient was seen in clinic approximately 2 weeks after implant of the maestro rechargeable system.Upon initial device interrogation, the alarm code indicating the implanted device had been shut down due to a magnet swipe.The patient did not recall being near any strong magnets.Therapy was restarted.During the week of (b)(6) 2016, it was again reported that the device was again shut down with alarm code indicating this was due to a magnet swipe.Therapy was again restarted without adverse impact to the patient.Update: during a clinic visit on (b)(6) 2016, codes were cleared including 10 (therapy diagnostic failure), 28 (cannot calibrate anterior output), and 30 (during one of the safety checks, an output circuitry error was detected).The patient was asked about magnetic interference that could be causing the events.The patient is unaware of any strong magnets, but indicated that the problem only occurs when charging is attempted upstairs in her home.Therapy was again restarted without adverse impact to the patient.On (b)(6) 2016, the patient reported that the flashing red light (indicating therapy is no longer being delivered) has returned.
Event or Problem Description
Patient was seen in clinic approximately 2 weeks after implant of the maestro rechargeable system.Upon initial device interrogation, the alarm code was indicating the implanted device had been shut down due to a magnet swipe.The patient did not recall being near any strong magnets.Therapy was restarted.During the week of (b)(6) 2016, it was again reported that the device was again shut down with alarm code indicating this was due to a magnet swipe.Therapy was again restarted without adverse impact to the patient.(b)(4).The patient was asked about magnetic interference that could be causing the events.The patient is unaware of any strong magnets, but indicated that the problem only occurs when charging is attempted upstairs in her home.Therapy was again restarted without adverse impact to the patient.On (b)(6) 2016, the patient reported that the flashing red light (indicating therapy is no longer being delivered) has returned.Update 002: the maestro rechargeable system was explanted uneventfully on (b)(6) 2017.
Event or Problem Description
Patient was seen in clinic approximately 2 weeks after implant of the maestro rechargeable system.Upon initial device interrogation, the alarm code was indicating the implanted device had been shut down due to a magnet swipe.The patient did not recall being near any strong magnets.Therapy was restarted.During the week of (b)(4) 2016, it was again reported that the device was again shut down with alarm code indicating this was due to a magnet swipe.Therapy was again restarted without adverse impact to the patient.Update: during a clinic visit on (b)(6) 2016, codes were cleared including 10 (therapy diagnostic failure), 28 (cannot calibrate anterior output), and 30 (during one of the safety checks, an output circuitry error was detected).The patient was asked about magnetic interference that could be causing the events.The patient is unaware of any strong magnets, but indicated that the problem only occurs when charging is attempted upstairs in her home.Therapy was again restarted without adverse impact to the patient.On (b)(4) 2016, the patient reported that the flashing red light (indicating therapy is no longer being delivered) has returned.Update: the maestro rechargeable system was explanted uneventfully on (b)(4) 2017.Update: the explanted maestro rechargeable system was received by enteromedics for evaluation on february 15, 2017.
Event or Problem Description
Patient was seen in clinic approximately 2 weeks after implant of the maestro rechargeable system.Upon initial device interrogation, the alarm code indicating the implanted device had been shut down due to a magnet swipe.The patient did not recall being near any strong magnets.Therapy was restarted.During the week of (b)(6) 2016, it was again reported that the device was again shut down with alarm code indicating this was due to a magnet swipe.Therapy was again restarted without adverse impact to the patient.Update 001: during a clinic visit on (b)(6) 2016, codes were cleared including 10 (therapy diagnostic failure), 28 (cannot calibrate anterior output), and 30 (during one of the safety checks, an output circuitry error was detected).The patient was asked about magnetic interference that could be causing the events.The patient is unaware of any strong magnets, but indicated that the problem only occurs when charging is attempted upstairs in her home.Therapy was again restarted without adverse impact to the patient.On (b)(6) 2016, the patient reported that the flashing red light (indicating therapy is no longer being delivered) has returned.Update 002: the maestro rechargeable system was explanted uneventfully on (b)(6) 2017.Update 003: the explanted maestro rechargeable system was received by enteromedics for evaluation on (b)(6) 2017.Update 004: component evaluation completed march 23, 2017.

• 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: 5772692
• Report Number: 3005025697-2016-00007
• Device Sequence Number: 686373
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/12/2017

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: 06/10/2016
• 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: 02/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/03/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/06/2016
• Supplement Report FDA Received Date: 12/07/2016; 02/16/2017; 03/15/2017; 04/12/2017
• 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: Other
• Patient Age: 47 YR
• Patient Weight: 113