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

Model Number	2200P-47E
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem 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 or Problem 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
• Common Device Name: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6000074
• Report Number: 3005025697-2016-00011
• Device Sequence Number: 867765
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2017

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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 101