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

Model Number 2002

Device Problems Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)

Patient Problem Failure of Implant (1924)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

Device still implanted; not returned.

Event Description

This recharge clinical trial subject was implanted with the maestro rechargeable system on (b)(6) 2011.This subject has experienced several magnet swipe deactivations of the implanted rechargeable neuroregulator, that were initially reported on (b)(6) 2016.On (b)(6) 2016 additional information was received indicating multiple additional unanticipated deactivations of the rnr on (b)(6) 2016 with no associated magnet deactivation code.At last report, this subject is currently receiving therapy from the implanted device.

• 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: lisa pritchard ; 2800 patton road; saint paul, MN 55113 ; 6517892681
• MDR Report Key: 6237405
• MDR Text Key: 64355934
• Report Number: 3005025697-2017-00002
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/29/2012
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093511911A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2011
• 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
• Treatment: EZETROL 10 MG; MULTIVITAMIN
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 101