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

Model Number	2200P-47E
Medical Device Problem Codes	Device Inoperable (1663); Use of Device Problem (1670); Low impedance (2285); Device Displays Incorrect Message (2591); Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
A former subject in the empower clinical trial (ide (b)(4); (b)(6)) was converted to a maestro rechargeable system on (b)(6) 2015.At the conversion procedure, the original investigational rf neuroregulator was replaced with the commercial model 2002 rechargeable neuroregulator.The anterior and posterior leads, implanted as part of the empower clinical trial on (b)(6) 2008, were not replaced at the time of the conversion to the rechargeable system.On (b)(6) 2015 the site reported that this patient was experiencing low impedance of the anterior lead with related error codes.Therapy was restarted but then the issue returned.Review of radiograph images suggest that this issue was caused by excessive device manipulation by the patient.The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016.Mdrs related to this issue are: mdr3005025697-2017-00005: model 2002 rechargeable neuroregulator; mdr3005025697-2017-00006: model 2200a-47e anterior lead; mdr3005025697-2017-00007: model 2200p-47e posterior lead.

• 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: 6370136
• Report Number: 3005025697-2017-00007
• Device Sequence Number: 1056205
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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: 02/01/2008
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: C2-09269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2016
• Initial Report FDA Received Date: 03/01/2017
• 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: BUSCOPAN; IBUPROFEN; OXYCODONE; PARACETAMOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Weight: 122