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

Model Number 2200A-47E

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

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

Event Date 01/12/2017

Event Type  malfunction  

Event Description

Subject participating in the (b)(6).This subject was implanted with the maestro rechargeable system on (b)(6) 2011.During a clinic visit on (b)(6) 2016, error codes were received for low impedance of the anterior lead and too many therapy retries.Alarms were cleared and therapy resumed.Therapy was again interrupted from (b)(6) 2016.During a clinic visit on (b)(6) 2016, the same error codes as occured on (b)(6) 2016 were cleared and therapy was resumed.On (b)(6) 2017 an anterior tip to anterior ring short was experienced again.The device was explanted on (b)(6) 2017.Extreme scarring and adhesions were noted at explant.However, the entire device was able to be explanted.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: ANTERIOR 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: katherine tweden ; 2800 patton road; saint paul, MN 55113 ; 6516343209
• MDR Report Key: 6316569
• MDR Text Key: 67233582
• Report Number: 3005025697-2017-00004
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004286
• UDI-Public: 00857334004286
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Device Lot Number: C4-07862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2011
• 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: 60 YR
• Patient Weight: 109