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

Model Number	2002
Medical Device Problem Code	Battery Problem: Low Impedance (2973)
Health Effect - Clinical Codes	Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was not originally reported.After engineering reviewed the cp log data, it was determined the root cause of the customer's experience was likely a damaged anterior lead.
Event or Problem Description
Patient subject (b)(6) at (b)(6) who was originally an empower patient and has converted to the rechargeable system.The patient was experiencing a flashing red light on their mc.Reshape's field specialist met the patient on (b)(4) 2018.When connected to the cp, error codes #25 and #4 were displayed and cleared.The on demand impedances were as follows: 954, 1198, 795, and 804, 735, 6548.The therapy was restarted.A live test was performed and the patient was sent home receiving therapy.On may 18, 2018, reshape received additional information when the field specialist visited the site.After reviewing the logs, the patient received therapy for 13 days before a low impedance alarm was triggered.The cp cleared the alarms and on demand impedance measurements were performed as followed: 960, 1211, 781 and 967, 1241, 781.Another live test was performed and the patient was sent home receiving therapy.

• 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: 7795492
• Report Number: 3005025697-2018-00008
• Device Sequence Number: 1468830
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: Lay User/Patient
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 08/17/2018
• 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