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

Model Number 2002

Device Problems Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Event Description

The device was implanted on (b)(6) 2016.The rnr had a flashing red light during implantation, half-way through patient registration with the cp.The rnr was replaced and the case was successfully completed.

• Brand Name: MAESTRO RECHARGABLE SYSTEM
• Type of Device: RECHARGABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE MEDICAL; 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: 7466433
• MDR Text Key: 107196174
• Report Number: 3005025697-2018-00006
• 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 Expiration Date: 03/02/2017
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093G13315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• 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