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

Model Number 2200P-47E

Device Problems Electrical /Electronic Property Problem (1198); High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

A subject participating in the recharge clinical trial (subject id (b)(4)) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011.On (b)(6) 2015, this subject underwent replacement of the anterior lead and rechargeable neuroregulator, with no replacement of the posterior lead at that time.On (b)(6) 2016, the site reported that the patient had a flashing red light during attempted charging.During a clinic visit on (b)(6) 2016, an error message (code 12: pulse current below minimum threshold) was encountered.This code was cleared during the visit.Later in the day on (b)(6) 2016, the subject again reported a flashing red light.On (b)(6) 2016, the subject was again seen in the clinic.Several error messages were encountered (code 12: pulse current below minimum threshold, code 25: too many therapy retries, and code 3: high impedance).This subject is not receiving therapy from the device.

Event Description

A subject participating in the (b)(6) clinical trial (subject (b)(6)) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011.On (b)(6) 2015, this subject underwent replacement of the anterior lead and rechargeable neuroregulator, with no replacement of the posterior lead at that time.On (b)(6) 2016, the site reported that the patient had a flashing red light during attempted charging.During a clinic visit on (b)(6) 2016, an error message (code 12: pulse current below minimum threshold) was encountered.This code was cleared during the visit.Later in the day on (b)(6) 2016, the subject again reported a flashing red light.On (b)(6) 2016, the subject was again seen in the clinic.Several error messages were encountered (code 12: pulse current below minimum threshold, code 25: too many therapy retries, and code 3: high impedance).This subject is not receiving therapy from the device.Update: the posterior lead and rechargeable neuroregulator were replaced on (b)(6) 2016.No issues were encountered during the revision procedure.

• 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: lisa pritchard ; 2800 patton road; saint paul, MN 55113 ; 6517892681
• MDR Report Key: 6000074
• MDR Text Key: 56555424
• Report Number: 3005025697-2016-00011
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• 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: C4-07889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2011
• 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
• Treatment: (B)(4) 2 TABS PRN; (B)(4) SLEEP AID 1/4 TAB PRN; ATORVASTATIN 10 MG; FLUOXETINE 20 MG; HALOBETASOL PROPRIONATE 0.5%; METHYLPHENIDATE HCL 1 TAB PRN
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 101