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

Model Number 2002

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591); Electrical Overstress (2924)

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

Event Date 12/04/2015

Event Type  malfunction  

Event Description

Subject participating in the recharge clinical trial ((b)(4)) turned the maestro rechargeable neuroregulator (rnr) off prior to undergoing an unrelated laparoscopic oophorectomy surgery in (b)(6) 2015.Following this unrelated surgery, the rnr could not be turned back on with the clinician programmer.Two error codes were encountered: # 10 (hv supply out of range) and #30 (output circuitry failure).Enteromedics field clinical engineering attempted re-start on (b)(6), 2015.At this time, three error codes were encountered: #10 (hv supply out of range), #25 (too many therapy restarts) and #30 (output circuitry failure).Therapy could not be restarted.Initial review indicated codes may be resolved without revision or explant, with no resulting impact to subject.Following detailed review of log data from this issue, it was determined on (b)(6), 2015 that surgical revision would be required to restore therapy.Therefore, this event was then considered to be a reportable event.A follow-up report will be completed after revision procedure and investigation of returned components, if applicable.

Event Description

Subject participating in the recharge clinical trial ((b)(4)) turned the maestro rechargeable neuroregulator (rnr) off prior to undergoing an unrelated laparoscopic oophorectomy surgery in (b)(6) 2015.Following this unrelated surgery, the rnr could not be turned back on with the clinician programmer.Two error codes were encountered: # 10 (hv supply out of range) and #30 (output circuitry failure).Enteromedics field clinical engineering attempted re-start on august 27, 2015.At this time, three error codes were encountered: #10 (hv supply out of range), #25 (too many therapy restarts) and #30 (output circuitry failure).Therapy could not be restarted.Initial review indicated codes may be resolved without revision or explant, with no resulting impact to subject.Following detailed review of log data from this issue, it was determined on (b)(6) 2015 that surgical revision would be required to restore therapy.Therefore, this event was then considered to be a reportable event.A follow-up report will be completed after revision procedure and investigation of returned components, if applicable.Update: the maestro rechargeable neuroregulator was replaced without incident on (b)(6) 2015.

• 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: 5204067
• MDR Text Key: 30477791
• Report Number: 3005025697-2015-00004
• 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: health professional,study
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/11/2016
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: NR-000278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2014
• 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: 39 YR
• Patient Weight: 109