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

Model Number	2200P-47E
Medical Device Problem Codes	High impedance (1291); Device Inoperable (1663)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Event or Problem Description
High impedance of the posterior lead was experienced during an initial implant procedure of the maestro rechargeable system in this patient.After confirming this was not caused by the connection of the lead to the neuroregulator, the posterior lead was replaced during the same procedure.The replacement posterior lead also resulted in high impedance so was also replaced and the procedure completed.Both posterior leads that resulted in high impedance measurements were returned for analysis.This mdr covers investigation of the first posterior lead that was replaced (serial number (b)(4)).Refer to mdr3005025697-2017-00021 for report of the second posterior lead that was replaced during the procedure (serial number (b)(4)).

• 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: 6814585
• Report Number: 3005025697-2017-00020
• Device Sequence Number: 1761022
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: 05/01/2020
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: C4-12858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 08/23/2017
• 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