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

Model Number 2200A-47E

Device Problems Device Inoperable (1663); Use of Device Problem (1670); Low impedance (2285); Device Displays Incorrect Message (2591); Impedance Problem (2950); Material Twisted/Bent (2981)

Patient Problems Failure of Implant (1924); Twiddlers Syndrome (2114); Therapeutic Response, Decreased (2271)

Event Date 09/21/2016

Event Type  Injury  

Event Description

A former subject in the (b)(6) clinical trial (ide (b)(4); subject id (b)(6)) was originally converted to a maestro rechargeable system on (b)(6) 2015.The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016 (refer to mdr 3005025697-2017-00005 through mdr 3005025697-2017-00007 for details on original rechargeable system removal due to excessive manipulation).On (b)(6) 2016, the site reported that alerts for low impedance were experienced at follow-up, noting that the ring electrodes were places quite close together at implant.On (b)(6) 2016, it was reported that low impedance measurements were again experienced.Radiograph review suggested that the ring electrodes were in very close proximity to each other with twisting of the leads near the neuroregulator.The replacement system was explanted on (b)(6) , 2016.Mdr's related to this issues are: mdr 3005025697-2017-00008: model 2002 rechargeable neuroregulator, mdr 3005025697-2017-00009: model 2200a-47e anterior lead, mdr 3005025697-2017-00010: model 2200p-47e posterior lead.

• 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: katherine tweden ; 2800 patton road; saint paul, MN 55113 ; 6516343209
• MDR Report Key: 6370103
• MDR Text Key: 68752205
• Report Number: 3005025697-2017-00009
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004286
• UDI-Public: 00857334004286
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 03/01/2017
• 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
• Treatment: BUSCOPAN; IBUPROFEN; OXYCODONE; PARACETAMOL
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 122