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

Model Number 2200P-47E

Device Problems Electrical /Electronic Property Problem (1198); Material Separation (1562); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591); Material Distortion (2977)

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

Event Date 05/03/2016

Event Type  malfunction  

Event Description

A subject participating in the (b)(6) trial (subject id (b)(6)) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011.This subject has had a history of multiple low impedance events related to the implanted posterior lead, resulting in a need to restart therapy.Reported low impedance events for this subject occurred on (b)(6) 2014, (b)(6) 2015, (b)(6) 2016, and a final report of continued impedance issues on (b)(6) 2016.On (b)(6) 2016, it was also reported that this subject is unreliable with charging and attending clinic visits.On april 27, 2017, enteromedics was informed that this subject has decided to have the device explanted.The device was subsequently explanted without incident on (b)(6) 2017.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: POSTERIOR LEAD
• 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: 6589485
• MDR Text Key: 75923996
• Report Number: 3005025697-2017-00013
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• 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: foreign,health professional,s
• Reporter Occupation: Physical Therapist
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2014
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: C4-07865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 98