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

Model Number 2002

Device Problems Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 11/06/2015

Event Type  malfunction  

Event Description

Communication issues were encountered during implantation of the maestro rechargeable system.Error messages encountered included: error code 06 (brown out condition) and an error indicating that the rechargeable neuroregulator (rnr) had been subjected to a magnet swipe.Attempts to re-boot the clinician programmer and replace external system components (transmit coils and mobile charger) used during the implant did not resolve the issues.It was therefore decided not to implant the rnr, and use an alternate rnr instead.The implantation procedure was completed without adverse impact to the patient.Upon return of the rnr, investigation determined this implantable component, which was not yet implanted, to have a malfunction (poor connection of a component on the circuit assembly) which resulted in the communication issues.

• 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: 5278708
• MDR Text Key: 33067623
• Report Number: 3005025697-2015-00005
• 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: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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