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

Model Number	2002
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device still implanted; not returned.
Event or Problem Description
This patient was implanted with the maestro rechargeable system on (b)(6) 2016.Patient was unable to charge their rechargeable neuroregulator (rnr) for an extended period of time due to an issue with an external system component.This resulted in disconnection of the rnr battery and discontinuation of therapy.During a clinic visit to reconnect the rnr battery on (b)(6) 2016, a charge of the rnr battery could not be initiated.The rnr went from the application mode into the bootloader mode of operation and a brownout code was encountered.An unexpected response code (nak) was received.The rnr battery could not be reconnected and therapy could not be restarted.
Event or Problem Description
This patient was implanted with the maestro rechargeable system on (b)(6) 2016.Patient was unable to charge their rechargeable neuroregulator (rnr) for an extended period of time due to an issue with an external system component.This resulted in disconnection of the rnr battery and discontinuation of therapy.During a clinic visit to reconnect the rnr battery on (b)(6)2016, a charge of the rnr battery could not be initiated.The rnr went from the application mode into the bootloader mode of operation and a brownout code was encountered.An unexpected response code (nak) was received.The rnr battery could not be reconnected and therapy could not be restarted.Update: recharging was unsuccessfully attempted on (b)(6) 2016 in clinic with field clinical engineer.It was determined that charging was prevented due to an elevated baseline temperature of the rechargeable neuroregulator.Successful recharge of the rechargeable neuroregulator was achieved on (b)(6) 2016 using a procedure developed to recover a disconnected battery with a high baseline temperature.No rnr safety parameters were modified and it was ensured that maximum implant temperature during charging was below 42c in accordance with product specifications.Normal therapy delivery was resumed.

• 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: 6137999
• Report Number: 3005025697-2016-00014
• Device Sequence Number: 13735322
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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: 06/10/2016
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093G29714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 03/01/2017
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 113