MAUDE Adverse Event Report: RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR

Model Number 2002

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Failure of Implant (1924)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

A large impedance change was encountered and is most likely the cause of the error codes that were captured.This large impedance change can result in error codes being generated in a system that is functioning within specifications.Possible causes for this include variations in the interface between the nerve and electrodes, tension being placed on the leads during the impedance check, or inadequate connection between the leads and the rechargeable neuroregulator.No evidence for the specific cause of the high impedance change that was encountered could be positively identified for this event.

Event Description

This patient underwent implantation of the maestro rechargeable system on (b)(6) 2017.High impedance readings were received after connection of the rechargeable neuroregulator and application of medical adhesive.Two error codes were then received: code 10 (therapy diagnostic failure) and code 30 (safety check failed).The rechargeable neuroregulator (rnr) was removed during this same procedure and replaced with another rnr without incident.Impedance measurements following replacement of the rnr were within normal range.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: randy hoyt ; 2800 patton road; saint paul, MN 55113 ; 6517892671
• MDR Report Key: 7185079
• MDR Text Key: 97382152
• Report Number: 3005025697-2018-00002
• 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
• Report Date: 01/11/2018

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
• Device Operator: Physician
• Device Expiration Date: 05/07/2019
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093G13817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2017
• 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