MAUDE Adverse Event Report: RESHAPE LIFESCIENCES MAESTRO RECHARGEABLE SYSTEM; RECHARGEABLE NEUROREGULATOR

Model Number	2002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
This patient was implanted with the maestro rechargeable system on (b)(6) 2016.On (b)(6) 2016, the patient visited the emergency room and was treated for apparent infection with iv antibiotics.The patient was not admitted to the hospital, but was sent home the same day on oral antibiotics (bactrium).Patient was on bactrium from (b)(6) 2016 through (b)(6) 2017.At a clinic visit on (b)(6) 2017, the incision was reported to appear as if it was healing normally.No further reports have been received for this patient.This mdr covers investigation of the rechargeable neuroregulator.Refer to mdr3005025697-2017-00025 for report of the anterior lead and mdr3005025697-2017-00026 for report of the posterior lead.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: RECHARGEABLE NEUROREGULATOR
• Manufacturer (Section D): RESHAPE LIFESCIENCES; 2800 patton road; saint paul MN 55113
• MDR Report Key: 7116892
• Report Number: 3005025697-2017-00024
• Device Sequence Number: 1879907
• Product Code: PIM
• UDI-Device Identifier: 00857334004262
• UDI-Public: 00857334004262
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 02/05/2017
• Device Model Number: 2002
• Device Catalogue Number: 2002
• Device Lot Number: 093G19115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 12/14/2017
• 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