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

Model Number 2200A-47E

Device Problems Failure to Conduct (1114); Disconnection (1171); Electrical /Electronic Property Problem (1198); High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591); Material Distortion (2977); Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Therapeutic Response, Decreased (2271)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

Device still implanted; not 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.Subject noticed a flashing red light that was reported on (b)(6) 2016.During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead.Therapy is not being delivered.

Manufacturer Narrative

Device not yet returned.

Event Description

This subject is a participant in the recharge 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.Subject noticed a flashing red light that was reported on (b)(6) 2016.During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead.Therapy is not being delivered.Supplement 001: subject underwent revision of the maestro rechargeable system on (b)(6) 2017.Because the anterior lead was twisted with the posterior lead, all device components were replaced.Revision procedure was successfully completed without adverse impact to subject.Explanted device components have not yet been received by enteromedics.Reference mdr 3005025697-2017-00014 for report related to the posterior lead.

Event Description

This subject is a participant in the recharge 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.Subject noticed a flashing red light that was reported on (b)(6) 2016.During a clinic visit on (b)(6) 2016, it was reported that the subject has an open circuit of the implanted anterior lead.Therapy is not being delivered.Supplement 001: subject underwent revision of the maestro rechargeable system on (b)(6) 2017.Because the anterior lead was twisted with the posterior lead, all device components were replaced.Revision procedure was successfully completed without adverse impact to subject.Explanted device components have not yet been received by enteromedics.Reference mdr 3005025697-2017-00014 for report related to the posterior lead.Supplement 002: explanted device components received on (b)(6) 2017.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Type of Device: ANTERIOR 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: 6237397
• MDR Text Key: 64356143
• Report Number: 3005025697-2017-00001
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004286
• UDI-Public: 00857334004286
• 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,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• 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: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Device Lot Number: CR-01825
• 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
• Date Device Manufactured: 01/24/2014
• 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
• Treatment: ALEVE PRN
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 114