MAUDE Adverse Event Report: ENTEROMEDICS, INC. MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR

Model Number 2002

Device Problems Failure to Charge (1085); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  malfunction  

Event Description

This patient was implanted with the maestro rechargeable system on (b)(6) 2017.This subject has reported issues charging the implanted rechargeable neuroregulator.Using a charged mobile charger, communication required for charging could not be maintained.Upon device interrogation, no alarms or error codes were noted.An alarm clearing sequence was run during a clinic visit on (b)(6) 2017.Following this, a charge was successfully initiated.Patient left the clinic receiving therapy.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: randy hoyt ; 2800 patton road; saint paul, MN 55113 ; 6517892671
• MDR Report Key: 6958720
• MDR Text Key: 90533531
• Report Number: 3005025697-2017-00023
• 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: Other
• Type of Report: Initial
• Report Date: 10/18/2017

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: Physician
• Device Expiration Date: 08/10/2017
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093G00716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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): Other
• Patient Age: 47 YR
• Patient Weight: 113