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

Model Number 2002

Device Problems Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

This patient underwent implantation of the maestro rechargeable system on (b)(6) 2015.An unanticipated shutdown event of the rechargeable neuroregulator (rnr) was reported on (b)(6) 2017.Multiple attempts to reset the real time clock, clear the unintended shutdown error code, and reconnect the battery in the rnr were unsuccessful.Therapy delivery could not be re-established.

• 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: katherine tweden ; 2800 patton road; saint paul, MN 55113 ; 6516343209
• MDR Report Key: 6504798
• MDR Text Key: 73253391
• Report Number: 3005025697-2017-00011
• 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: 04/19/2017

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: 06/10/2016
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093G29714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2014
• 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
• Patient Age: 47 YR
• Patient Weight: 113