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

Model Number 2002

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271); Patient Problem/Medical Problem (2688)

Event Date 01/19/2017

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Device remains implanted; not returned.

Event 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 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 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 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
• Type of Device: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: katherine tweden ; 2800 patton road; saint paul, MN 55113 ; 6516343209
• MDR Report Key: 5772692
• MDR Text Key: 48869321
• Report Number: 3005025697-2016-00007
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 113