MAUDE Adverse Event Report: RESHAPE MEDCIAL MAESTRO RECHARGABLE SYSTEM; RECHARGABLE NEUROREGULATOR

Model Number 2002

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2016

Event Type  malfunction  

Event Description

The rnr was implanted on (b)(6) 2016, the dissection and lead placement went well.The leads were connected to the rnr and initial impedance measurements were 688, 883, and 953.Therapy was then activated.Before a live test could be performed, the cp displayed error code #14, regulator hv voltage above max threshold.The error code box was closed and then the cp immediately ended the session.The reshape clinical field specialist attempted to reconnect the rnr three more times and the same error message would appear and then close the session.A new rnr was registered and implanted successfully without any issues.

• Brand Name: MAESTRO RECHARGABLE SYSTEM
• Type of Device: RECHARGABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE MEDCIAL; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): RESHAPE MEDICAL; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: kristin wielenga ; 2800 patton road; saint paul, MN 55113 ; 9492188639
• MDR Report Key: 7466427
• MDR Text Key: 107196113
• Report Number: 3005025697-2018-00005
• 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
• Type of Report: Initial
• Report Date: 04/26/2018

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: Physician
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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