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

Model Number 2002

Device Problems Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2016

Event Type  malfunction  

Event 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
• Type of Device: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE MEDICAL; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): RESHAPE MEDICAL; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: kristin wielenga ; 2800 patton road; saint paul, CA 55113 ; 9492188639
• MDR Report Key: 7466424
• MDR Text Key: 106955237
• Report Number: 3005025697-2018-00004
• 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: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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