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

Model Number 2200P-47E

Device Problems Bent (1059); Electrical /Electronic Property Problem (1198); Material Separation (1562); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591); Material Deformation (2976)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

(b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.

Event Description

An (b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.Supplement 001: this subject underwent successful explant of the complete maestro rechargeable system on (b)(6) 2017.No adverse events were reported with the explant procedure.No explanted components have been received by enteromedics.

Event Description

An (b)(6) subject participating in the (b)(6) clinical trial (subject id (b)(6)), was originally implanted with a sham control device (sham neuroregulator) on (b)(6) 2011.This subject subsequently underwent conversion to the active maestro rechargeable system, with an active rechargeable neuroregulator, anterior lead and posterior lead implanted on (b)(6) 2013.On (b)(6) 2016, low impedance of the posterior lead was detected during a clinic visit.The associated alerts were cleared during the visit, but recurred within 24 hours.As a result, this subject is not receiving therapy from the device.Supplement 001: this subject underwent successful explant of the complete maestro rechargeable system on (b)(6) 2017.No adverse events were reported with the explant procedure.No explanted components have been received by enteromedics.Supplement 002: explanted device received for analysis on november 6, 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: 6000063
• MDR Text Key: 56481576
• Report Number: 3005025697-2016-00009
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/01/2014
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: 11716-555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• 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
• Treatment: CODRAL 1 TAB PRN; ESOMEPRAZOLE 40 MG; FISH OIL 3 TABS; PARACETOMOL 1000 MG PRN; PSEUDOEPHEDRINE HYDROCHLORIDE 20 MG PRN
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 104