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

Model Number	2002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Shock from Patient Lead(s) (3162)
Date of Event	10/15/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported that she feels a zap in the right side of her abdomen which results in unbearable pain.She experiences it at least once or twice a week and the episodes last for 20-30 mins.She believes that it is related to the implant and let the battery die completely.She hasn't received therapy since (b)(6) and hasn't had one of those episodes since.The physician feels that it might not be related to the device but has something to do with her gallbladder.The patient agreed to give try again for 2 weeks so the device was restarted.The device was recharged, therapy was adjusted to 10 hours per day, and the patient was trained how to turn the device off in case the pain returns.The patient returned approximately 2 weeks later with the same issue.She had one of those episodes on the same day we turned her device back on.She feels that the devices makes her extremely gassy and bloated also.The device was turned off.The patient wants to wait and watch for a month to see if there is any improvement.
Event or Problem Description
The patient reported that she feels a zap in the right side of her abdomen which results in unbearable pain.She experiences it at least once or twice a week and the episodes last for 20-30 mins.She believes that it is related to the implant and let the battery die completely.She hasn't received therapy since (b)(6) and hasn't had one of those episodes since.The physician feels that it might not be related to the device but has something to do with her gallbladder.The patient agreed to give try again for 2 weeks so the device was restarted.The device was recharged, therapy was adjusted to 10 hours per day, and the patient was trained how to turn the device off in case the pain returns.The patient returned approximately 2 weeks later with the same issue.She had one of those episodes on the same day we turned her device back on.She feels that the devices makes her extremely gassy and bloated also.The device was turned off.The patient wants to wait and watch for a month to see if there is any improvement.
Additional Manufacturer Narrative
Follow up with the physician's office on (b)(6) 2018 found that the device remains implanted and powered down at the patients request.A review of the manufacturing lot history did not identify any concerns.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: RECHARGABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• MDR Report Key: 7293913
• Report Number: 3005025697-2018-00003
• Device Sequence Number: 1342959
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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
• Operator of Device: Physician
• Device Expiration Date: 11/23/2018
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: NR-000418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention