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

Model Number P01367-001

Device Problem Low impedance (2285)

Patient Problem Failure of Implant (1924)

Event Date 06/20/2019

Event Type  malfunction  

Event Description

Patient observed a red light on the mobile charger and was unable to charge device.The patient reached out to the clinical site to schedule a visit.Upon communication with device using the clinical programmer, error code 4 was observed, "too many therapy retries".Patient will be going to the office for a visit on (b)(6) 2019 to have the log files downloaded onto a usb drive.Errors are due to low impedance on the device leads.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: RECHARGEABLE NEUROREGULATOR,
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: kristin wielenga ; 2800 patton road; saint paul, MN 55113 ; 9492188639
• MDR Report Key: 8802628
• MDR Text Key: 151465719
• Report Number: 3005025697-2019-00005
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004347
• UDI-Public: 00857334004347
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/18/2019

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: Health Professional
• Device Model Number: P01367-001
• Device Catalogue Number: MC MODEL 2402, US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/18/2019
• 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