MAUDE Adverse Event Report: RESHAPE LIFE SCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR

Model Number 2002

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, patient (b)(6) at the university (b)(6) was unable to charge the device and had a flashing red light on the mc.The reshape lifesciences field specialist connected her to the cp and alarm codes #4 and #25 were observed.These alarms were cleared and the flashing red light disappeared.The cp continued to ask to start a charge as the rnr battery was extremely low.After about 15 minutes of charging using the patients mc, therapy was able to be adjusted and a live test performed.On-demand impedance measurement was performed and the results were as follows: 934, 1033, 677.Before the patient left, another on-demand impedance test was performed, the readings were as follows: 821, 1062, 0.A red flashing light was observed on the mc.The patient was hooked up to the cp to clear the red light and was sent home.On (b)(6) 2018, the patient indicated they received another flashing red light.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFE SCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: randy hoyt ; 2800 patton road; saint paul, MN 55113 ; 6516343025
• MDR Report Key: 7848028
• MDR Text Key: 119828544
• Report Number: 3005025697-2018-00009
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2018

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: Lay User/Patient
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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