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

Model Number	2200A-47E
Medical Device Problem Codes	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)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device still implanted; not 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.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.
Additional Manufacturer Narrative
Device not yet returned.
Event or Problem 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 or Problem 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
• Common Device Name: ANTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6237397
• Report Number: 3005025697-2017-00001
• Device Sequence Number: 18919829
• Product Code: PIM
• UDI-Device Identifier: 00857334004286
• UDI-Public: 00857334004286
• 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,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: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 05/24/2017; 06/29/2017
• 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: ALEVE PRN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 114