MAUDE Adverse Event Report: RESHAPE LIFE SCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEBALE NEUROREGULATOR

Model Number 2002

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

Patient Problem Bruise/Contusion (1754)

Event Date 09/24/2018

Event Type  Injury  

Event Description

The patient had a vbloc device placed years ago in (b)(6) and has not charged or used the device in years.However, the patient has complained about a "lump growing in the same place as where the vbloc device is implanted." the patient claims there is potential bleeding as there is a growing bruise and the black and blue area is continuing to spread.The patient reported the affected area is about 6-7 inches and is experiencing sharp pains.It is unknown if the patient has had the vbloc explanted, the patient now lives in (b)(6), reshape lifesciences recommended to the patient to see a physician in the area.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: RECHARGEBALE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFE SCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): RESHAPE LIFE SCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: kristin wielenga ; 2800 patton road; saint paul, MN 55113
• MDR Report Key: 8018997
• MDR Text Key: 125466434
• Report Number: 3005025697-2018-00011
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/30/2018
• 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