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

Model Number 2200A-47E

Device Problems Electrical /Electronic Property Problem (1198); Fracture (1260); Overheating of Device (1437); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problems Bruise/Contusion (1754); Failure of Implant (1924); Therapeutic Response, Decreased (2271)

Event Date 11/04/2015

Event Type  malfunction  

Event Description

Subject participating in the recharge clinical trial ((b)(6)) experienced low impedance of anterior lead.Subject first reported a flashing red light on the mobile charger during a clinic visit on (b)(6), 2015, which was first noticed approximately (b)(6), 2015.During this visit, alarms were cleared for too many therapy retries and impedance too low.On (b)(6), 2015, upon request for additional information, the subject reported a bruise over the site of the implanted neuroregulator, with no associated discomfort or trauma.On (b)(6), 2015, the subject also reported that the neuroregulator had heated up some time between (b)(6), 2015 and the next charge session.At an additional clinic visit on (b)(6), 2015, an error code message "pulse current below minimum threshold" was reported, as well as an impedance reading of >65 kohms, indicating an open circuit.Therapy could not be re-started at this visit, in accordance with device design.Following review of reports and available device log data, surgical revision or explant was first recommended on (b)(6), 2015.Therefore, this event was then considered to be a reportable event.No serious injury or death has been experienced, or is anticipated, as a result of this event.A follow-up report will be completed after revision/explant procedure, if completed, and investigation of returned components, if available.

Event Description

Subject participating in (b)(6) experienced low impedance of anterior lead.Subject first reported a flashing red light on the mobile charger during a clinic visit on (b)(6) 2015, which was first noticed approximately (b)(6) 2015.During this visit, alarms were cleared for too many therapy retries and impedance too low.On (b)(6) 2015, upon request for additional information, the subject reported a bruise over the site of the implanted neuroregulator, with no associated discomfort or trauma.On (b)(6) 2015, the subject also reported that the neuroregulator had heated up some time between (b)(6) 2015 and the next charge session.At an additional clinic visit on (b)(6) 2015, an error code message "pulse current below minimum threshold" was reported, as well as an impedance reading of >65 kohms, indicating an open circuit.Therapy could not be re-started at this visit, in accordance with device design.Following review of reports and available device log data, surgical revision or explant was first recommended on (b)(6) 2015.Therefore, this event was then considered to be a reportable event.No serious injury or death has been experienced, or is anticipated, as a result of this event.A follow-up report will be completed after revision/explant procedure, if completed, and investigation of returned components, if available.Update: the anterior lead and rechargeable neuroregulator were replaced without incident on (b)(6) 2015, allowing therapy to resume.

• 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: 5189671
• MDR Text Key: 30386115
• Report Number: 3005025697-2015-00003
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• 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: 11580-1607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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: 53 YR
• Patient Weight: 105