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

Model Number 2002

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271)

Event Date 12/13/2016

Event Type  malfunction  

Manufacturer Narrative

Device still implanted; not returned.

Event 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 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
• 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: 6137999
• MDR Text Key: 61243795
• Report Number: 3005025697-2016-00014
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 113