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

Model Number	2002
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	06/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, patient 835-bam at skyridge experienced a red flashing light on the mc when connecting with the rnr at a post-op visit.The reshape field specialist tried several times to clear the flashing red lights when connected to the cp, however, the cp "locked up." the field specialist then hooked up another rnr (implant kit) to the cp, the red light disappeared and a green flashing light appeared on the mc signaling the patient was receiving therapy.The rnr logs were unable to upload due to the lock out on the cp, however, debug and data files were sent for investigation.On (b)(6) 2018, the field specialist met with the patient to attempt to connect the device to the cp again to clear the alarms.After several attempts, the cp was remained locked.The field specialist expressed to the implanting physician if they are unable to resolve this issue, revision surgery may be necessary.On (b)(6) 2018, the implanting physician performed revision surgery, removed the rnr and replaced with a new rnr.The device performed as expected and patient is doing well.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFE SCIENCES; 2800 patton road; saint paul MN 55113
• MDR Report Key: 7958255
• Report Number: 3005025697-2018-00010
• Device Sequence Number: 1386604
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 10/11/2018
• 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