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

Model Number P01278-001

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

Patient Problem Hematoma (1884)

Event Date 05/17/2019

Event Type  Injury  

Event Description

Patient (b)(6) had an explant on (b)(6) 2019 without complications and was discharged that day.The patient came back into the hospital on (b)(6) 2019 at 23:51 for left abdominal wall hematoma at the site of the previous neuromodulator device.The patient underwent surgery early this morning, (b)(6) 2019 for evacuation of the hematoma.The procedure went well and the patient was discharged the same day.

• 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: 8700542
• MDR Text Key: 148044973
• Report Number: 3005025697-2019-00003
• 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: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P01278-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• 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
• Patient Outcome(s): Required Intervention