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

Model Number 2200A-47E

Device Problems Electrical /Electronic Property Problem (1198); High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problems Adhesion(s) (1695); Failure of Implant (1924); Therapeutic Response, Decreased (2271)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted; not returned.

Event Description

(b)(6) subject participating in the (b)(6) clinical trial was implanted with the maestro rechargeable system on (b)(6) 2011.During a clinic visit on (b)(6) 2016, it was determined that a short circuit of the anterior lead had been experienced on (b)(6) 2016 and an anterior lead open circuit was experienced on (b)(6) 2016.This subject first reported a flashing red light on the mobile charger during the clinic visit on (b)(6) 2016.During this visit, alarms were noted for low rnr battery, the anterior tip to ring short circuit, and the anterior lead open circuit.Therapy was re-started at this visit, and alarms were cleared.Red light was reported by subject to have returned on (b)(6) 2016.During an additional clinic visit on (b)(6) 2016, alarm code 3 (impedance high) was encountered.Diagnostic evaluation reported by the site included another anterior lead tip to ring open circuit on (b)(6) 2016.

Event Description

(b)(6) subject participating in (b)(6) was implanted with the maestro rechargeable system on (b)(6) 2011.During a clinic visit on (b)(6) 2016, it was determined that a short circuit of the anterior lead had been experienced on (b)(6) 2016 and an anterior lead open circuit was experienced on (b)(6) 2016.This subject first reported a flashing red light on the mobile charger during the clinic visit on (b)(6) 2016.During this visit, alarms were noted for low rnr battery, the anterior tip to ring short circuit, and the anterior lead open circuit.Therapy was re-started at this visit, and alarms were cleared.Red light was reported by subject to have returned on (b)(6) 2016.During an additional clinic visit on (b)(6) 2016, alarm code 3 (impedance high) was encountered.Diagnostic evaluation reported by the site included another anterior lead tip to ring open circuit on (b)(6) 2016.Update: device was explanted on (b)(6) 2016.Extensive adhesions were noted during the explant.The entire maestro rechargeable system was removed.

• 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: 6137994
• MDR Text Key: 61243992
• Report Number: 3005025697-2016-00012
• 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: foreign,health professional,s
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2014
• Device Model Number: 2200A-47E
• Device Catalogue Number: 2200A-47E
• Device Lot Number: C4-07861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2011
• 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: IBUPROFEN 2 TABS PRN; PARACETAMOL 1000 MG PRN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 113