MAUDE Adverse Event Report: RESHAPE MEDICAL MAESTRO RECHARGABLE SYSTEM; RECHARGEABLE NEUROREGULATOR

Model Number	2002
Medical Device Problem Codes	Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2016, during initial phase of surgery prior to opening the device packaging, a reshape field clinical specialist was attempting to check the rnr battery level and status using the site mc and the site's physician coil.A red flashing status led was observed immediately.The field clinical specialist opened a cp session to interrogate rnr and read an alarm message relating to magnet swipe.The field clinical specialist attempted to follow prompts and clear alarm, however, the cp failed to clear alarm and presented additional error message regarding the reed switch closed and inability to correct issue, instructing user to contact emi.A new rnr was used, the cp was restarted prior to interrogating the new rnr per recommended cp shutdown method and the case was successfully completed.

• Brand Name: MAESTRO RECHARGABLE SYSTEM
• Common Device Name: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE MEDICAL; 2800 patton road; saint paul MN 55113
• MDR Report Key: 7466424
• Report Number: 3005025697-2018-00004
• Device Sequence Number: 10803101
• 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): 04/26/2018

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 Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2016
• Initial Report FDA Received Date: 04/26/2018
• 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