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

Model Number	2002
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	Therapeutic Response, Decreased (2271)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient visited the clinic on (b)(6) 2019 complaining of a flashing light on the mobile charger with an error code 25 displayed.The clinic reached out to reshape lifesciences field clinical specialist to report the issue and the field clinical specialist asked to have the patient brought back in for further investigation.On (b)(6) 2019, the patient was seen by the clinic.The device lead impedance on the anterior tip to posterior tip was 1583 ohms.With an impedance above 1500 ohms, therapy will not be delivered.The clinic suggested the patient have a complete removal of the device.The removal of the device is scheduled for (b)(6) 2019.
Event or Problem Description
The patient visited the clinic on (b)(6) 2019 complaining of a flashing light on the mobile charger with an error code 25 displayed.The clinic reached out to reshape lifesciences field clinical specialist to report the issue and the field clinical specialist asked to have the patient brought back in for further investigation.On (b)(6) 2019, the patient was seen by the clinic.The device lead impedance on the anterior tip to posterior tip was 1583 ohms.With an impedance above 1500 ohms, therapy will not be delivered.The clinic suggested the patient have a complete removal of the device.The removal of the device is scheduled for on (b)(6) 2019.

• 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: 8586248
• Report Number: 3005025697-2019-00001
• Device Sequence Number: 11159887
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 12/19/2019
• 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