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

Model Number 2200A-47E

Device Problems Device Inoperable (1663); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

Subject participating in the (b)(6) reported a flashing red light on (b)(6) 2017.During a clinic visit on (b)(6) 2017, multiple error code messages were reported including 12 (pulse current below minimum threshold), 3 (high impedence for 60 minutes), and 25 (too many therapy retries).Anterior lead tip to ring and anterior tip to posterior tip impedance readings of >65 kohms were also reported, indicating an open circuit.Therapy could not be re-started.

Event Description

Subject participating in the (b)(6) clinical trial (b)(4) reported a flashing red light on (b)(6) 2017.During a clinic visit on (b)(6) 2017, multiple error code messages were reported including 12 (pulse current below minimum threshold), 3 (high impedenace for 60 minutes), and 25 (too many therapy retries).Anterior lead tip to ring and anterior tip to posterior tip impedance readings of >65 kohms were also reported, indicating an open circuit.Therapy could not be re-started.Supplement 001: the maestro rechargeable system was explanted without incident on (b)(6) 2017.

• 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: randy hoyt ; 2800 patton road; saint paul, MN 55113 ; 6517892671
• MDR Report Key: 6504794
• MDR Text Key: 73254448
• Report Number: 3005025697-2017-00012
• 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: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/01/2017
• Device Model Number: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Device Lot Number: CR-01825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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
• Treatment: ALEVE (PRN); ATORVASTATIN 10 MG; COSTCO SLEEP AID (PRN); FLUOXETINE 20 MG; HALOBETASOL PROPRIONATE .05% (PRN); METHYLPHENIDATE HCL (PRN)
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 105