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

Model Number	2200A-47E
Medical Device Problem Codes	Low impedance (2285); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A former subject in the (b)(6) clinical trial, whose original investigational radio frequency system (anterior lead, posterior lead, and investigational rf neuroregulator) was implanted on (b)(6) 2008, underwent conversion to the maestro rechargeable system on (b)(6) 2016.At the conversion implant, the posterior lead was replaced and the investigational rf neuroregulator was replaced with the model 2002 rechargeable neuroregulator (rnr).The original anterior lead, implanted on (b)(6) 2008, was not replaced.On (b)(6) 2016, a low impedance alert was encountered and cleared.At this time, the test amplitude for his system was increased from 1 to 3 ma, which is typically done at the first follow-up visit.On (b)(6) 2016, the patient experienced a red light when attempting to charge the rnr.On (b)(6) 2016, during a clinic visit, a low impedance alert (code 4) and associated too many therapy retries alert (code 25) were encountered.These alerts were cleared and the red light did not re-appear during the visit.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: ANTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 5734210
• Report Number: 3005025697-2016-00005
• Device Sequence Number: 18833997
• Product Code: PIM
• UDI-Device Identifier: 00857334004286
• UDI-Public: 00857334004286
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2016

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: 06/01/2016
• Device Model Number: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Device Lot Number: C2-09136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2016
• Initial Report FDA Received Date: 06/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 126