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

Model Number 2002

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Shock from Patient Lead(s) (3162)

Event Date 10/15/2017

Event Type  Injury  

Event 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 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.

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
• Type of Device: RECHARGABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• MDR Report Key: 7293913
• MDR Text Key: 100890751
• Report Number: 3005025697-2018-00003
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• 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: 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
• Device Operator: 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 Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention