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

Model Number	2200P-47E
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Fracture (1260); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Failure of Implant (1924); Therapeutic Response, Decreased (2271)
Date of Event	08/12/2015
Type of Reportable Event	Malfunction
Event or Problem Description
A subject participating in the recharge clinical trial (subject id (b)(6) underwent initial implantation of the maestro rechargeable system on (b)(6) 2011.Subject presented with red light (b)(6) 2015.Interrogation with clinician programmer indicated posterior tip to ring short since (b)(6) 2015 with display of error message.Therapy was restarted by site.Same issue occurred (b)(6) 2015 and again on (b)(6) 2015 with therapy restarted after each event.Maestro rechargeable system was explanted on (b)(6) 2015.Subject experienced seroma following explant which resolved without surgical or medical intervention.

• Brand Name: MAESTRO RECHARGEABLE SYSTEM
• Common Device Name: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC.; 2800 patton road; saint paul MN 55113
• MDR Report Key: 6262399
• Report Number: 3005025697-2017-00003
• Device Sequence Number: 10969794
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physical Therapist
• Type of Report: Initial
• 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: 07/01/2014
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: C4-08020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2015
• Initial 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: BECOLIDE PUFFER 1 PUFF; BIAXIG 300 MG; ESOMEPRAZOLE MAGNESIUM 40 MG; PARACETAMOL 1000 MG; RABEPRAZOLE20 MG; SIMVASTATIN 20 MG; VENTOLIN PUFFER 1 PUFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 94