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

Model Number	2200A-47E
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Adhesion(s) (1695); Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	11/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted; not returned.
Event or Problem 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 or Problem 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
• Common Device Name: ANTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6137994
• Report Number: 3005025697-2016-00012
• Device Sequence Number: 1155175
• Product Code: PIM
• UDI-Device Identifier: 00857334004286
• UDI-Public: 00857334004286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P130019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2017

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: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 01/18/2017
• 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: IBUPROFEN 2 TABS PRN; PARACETAMOL 1000 MG PRN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 113