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

Model Number 2002

Device Problems Electrical /Electronic Property Problem (1198); High impedance (1291); Misconnection (1399); Device Inoperable (1663); Use of Device Problem (1670); Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/13/2016

Event Type  malfunction  

Event Description

Implantation of this maestro rechargeable system occurred on (b)(6) 2015.On (b)(6) 2016, a red light was experienced on the external mobile charger when attempting to charge the rechargeable neuroregulator (rnr).High tip to tip impedance measurements and open tip to ring impedance measurements were noted.On (b)(6) 2016, the impedance limits for this patient were temporarily increased based on therapy amplitude settings within allowable limits, to allow therapy delivery while tissue ingrowth occurred.On (b)(6) 2016, high impedance measurements were again reported.Device log data was received by enteromedics for analysis on (b)(6) 2016.Review of the log data indicates an issue with the rnr preventing delivery of therapy.Replacement of the rnr is required to restore therapy delivery, but has not yet been completed.Additional investigation will be completed if the rnr is replaced and returned to enteromedics.

Event Description

Implantation of this maestro rechargeable system occurred on (b)(6) 2015.On (b)(6) 2016, a red light was experienced on the external mobile charger when attempting to charge the rechargeable neuroregulator (rnr).High tip to tip impedance measurements and open tip to ring impedance measurements were noted.On (b)(6) 2016, the impedance limits for this patient were temporarily increased based on therapy amplitude settings within allowable limits, to allow therapy delivery while tissue ingrowth occurred.On (b)(6) 2016, high impedance measurements were again reported.Device log data was received by enteromedics for analysis on (b)(6) 2016.Review of the log data indicated a potential an issue with the rnr preventing delivery of therapy.A revision procedure was completed to replace the rnr component on (b)(6) 2016.Impedance readings at the revision were found to be within allowable limits.The explanted rnr component was returned to enteromedics for investigation.Investigation indicates no evidence of device malfunction.Update: rnr was replaced without incident on (b)(6) 2016.

• 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: lisa pritchard ; 2800 patton road; saint paul, MN 55113 ; 6517892681
• MDR Report Key: 5441334
• MDR Text Key: 38346634
• Report Number: 3005025697-2016-00001
• 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
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• 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: 03/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 113