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

Model Number	2200P-47E
Medical Device Problem Codes	High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
This patient experienced a flashing red light on their device approximately (b)(6) 2017.On (b)(6) 2017, the site reported that they could not restart therapy.The clinician programmer indicated error code 25 (too many therapy retries).Impedance testing indicated high posterior tip to ring and anterior tip to posterior tip impedance measurements.Device remains implanted, but therapy is not being delivered.
Additional Manufacturer Narrative
Engineering was unable to confirm the customers complaint as the rnr passed the final functional test and due to the condition of the leads after removal surgery, they were not able to be investigated.
Event or Problem Description
This patient experienced a flashing red light on their device approximately (b)(6), 2017.On (b)(6) 2017, the site reported that they could not restart therapy.The clinician programmer indicated error code 25 (too many therapy retries).Impedance testing indicated high posterior tip to ring and anterior tip to posterior tip impedance measurements.

• Brand Name: MAESTRO RECHARGABLE SYSTEM
• Common Device Name: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6814574
• Report Number: 3005025697-2017-00019
• Device Sequence Number: 13722588
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 12/01/2017
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: CR-01897
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 05/21/2018
• 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: 47 YR
• Patient Weight: 113