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

Model Number 2002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 04/19/2019

Event Type  Injury  

Event Description

The device was removed on (b)(6) 2019 after the patient experienced symptoms of indigestion and heartburn.

Event Description

The device was removed on (b)(6) 2019 after the patient experienced symptoms of indigestion and heartburn.

• 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: 8604095
• MDR Text Key: 144843271
• Report Number: 3005025697-2019-00002
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004347
• UDI-Public: 00857334004347
• Combination Product (y/n): N
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 04/24/2019
• 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