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

Model Number	2200P-47E
Medical Device Problem Codes	Device Inoperable (1663); Device Displays Incorrect Message (2591); Material Distortion (2977); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explanted device not yet returned.
Event or Problem Description
This subject is a participant in the (b)(6) clinical trial.This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014.Impedance issues were reported related to the implanted anterior lead (reference mdr3005025697-2017-00001 for information on that component).During a revision procedure to replace the anterior lead, it was discovered that the anterior lead and posterior lead were twisted around each other in the pocket of the rechargeable neuroregulator.As a result, the posterior lead was also replaced.The revision procedure was successfully completed without adverse impact to the subject.Explanted device components have not yet been received by enteromedics.Reference mdr3005025697-2017-00001 for report related to the anterior lead.
Event or Problem Description
This subject is a participant in the (b)(6) clinical trial.This subject was originally in the control arm of the trial and underwent implantation of the active maestro rechargeable system on (b)(6) 2014.Impedance issues were reported related to the implanted anterior lead (reference mdr 3005025697-2017-00001 for information on that component).During a revision procedure to replace the anterior lead, it was discovered that the anterior lead and posterior lead were twisted around each other in the pocket of the rechargeable neuroregulator.As a result, the posterior lead was also replaced.The revision procedure was successfully completed without adverse impact to the subject.Explanted device components have not yet been received by enteromedics.Reference mdr 3005025697-2017-00001 for report related to the anterior lead.Supplement 001: explanted device component received by enteromedics on june 1, 2017.

• 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: 6589490
• Report Number: 3005025697-2017-00014
• Device Sequence Number: 13697721
• 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: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2017

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: 01/01/2017
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: CR-01826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/29/2017
• 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: 64 YR
• Patient Weight: 114