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

Model Number 2002

Device Problem Battery Problem: Low Impedance (2973)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

This complaint was not originally reported.After engineering reviewed the cp log data, it was determined the root cause of the customer's experience was likely a damaged anterior lead.

Event Description

Patient subject (b)(6) at (b)(6) who was originally an empower patient and has converted to the rechargeable system.The patient was experiencing a flashing red light on their mc.Reshape's field specialist met the patient on (b)(4) 2018.When connected to the cp, error codes #25 and #4 were displayed and cleared.The on demand impedances were as follows: 954, 1198, 795, and 804, 735, 6548.The therapy was restarted.A live test was performed and the patient was sent home receiving therapy.On may 18, 2018, reshape received additional information when the field specialist visited the site.After reviewing the logs, the patient received therapy for 13 days before a low impedance alarm was triggered.The cp cleared the alarms and on demand impedance measurements were performed as followed: 960, 1211, 781 and 967, 1241, 781.Another live test was performed and the patient was sent home receiving therapy.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: randy hoyt ; 2800 patton road; saint paul, MN 55113 ; 6516343025
• MDR Report Key: 7795492
• MDR Text Key: 117616497
• Report Number: 3005025697-2018-00008
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• 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?: No
• Date Manufacturer Received: 04/24/2018
• 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