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

Model Number	2002
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• MDR Report Key: 7185079
• Report Number: 3005025697-2018-00002
• Device Sequence Number: 11257456
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/11/2018
• 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