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

Model Number 2200P-47E

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591); Material Distortion (2977); Material Twisted/Bent (2981)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Explanted device not yet returned.

Event 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 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
• Type of Device: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• Manufacturer Contact: randy hoyt ; 2800 patton road; saint paul, MN 55113 ; 6517892671
• MDR Report Key: 6589490
• MDR Text Key: 75967249
• Report Number: 3005025697-2017-00014
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 114