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

Model Number 2200P-47E

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

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

Event Date 03/30/2016

Event Type  Injury  

Event Description

A former subject in the empower clinical trial (ide (b)(4); (b)(6)) was converted to a maestro rechargeable system on (b)(6) 2015.At the conversion procedure, the original investigational rf neuroregulator was replaced with the commercial model 2002 rechargeable neuroregulator.The anterior and posterior leads, implanted as part of the empower clinical trial on (b)(6) 2008, were not replaced at the time of the conversion to the rechargeable system.On (b)(6) 2015 the site reported that this patient was experiencing low impedance of the anterior lead with related error codes.Therapy was restarted but then the issue returned.Review of radiograph images suggest that this issue was caused by excessive device manipulation by the patient.The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016.Mdrs related to this issue are: mdr3005025697-2017-00005: model 2002 rechargeable neuroregulator; mdr3005025697-2017-00006: model 2200a-47e anterior lead; mdr3005025697-2017-00007: model 2200p-47e posterior lead.

• 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: katherine tweden ; 2800 patton road; saint paul, MN 55113 ; 6516343209
• MDR Report Key: 6370136
• MDR Text Key: 68750175
• Report Number: 3005025697-2017-00007
• 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: foreign,health professional
• Reporter Occupation: Nurse
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2008
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: C2-09269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2007
• 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): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 122