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

Model Number 2002

Device Problem Activation Problem (4042)

Patient Problems Failure of Implant (1924); Therapeutic Response, Decreased (2271)

Event Date 06/04/2018

Event Type  malfunction  

Event 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
• Type of Device: RECHARGEABLE 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 ; 9492188639
• MDR Report Key: 7958255
• MDR Text Key: 123513163
• Report Number: 3005025697-2018-00010
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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