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

Model Number 2002

Device Problem Failure to Charge (1085)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/04/2019

Event Type  Injury  

Event 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 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
• Type of Device: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• MDR Report Key: 8586248
• MDR Text Key: 144266484
• Report Number: 3005025697-2019-00001
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (y/n): N
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention