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

Model Number 2200P-47E

Device Problems Electrical /Electronic Property Problem (1198); Fracture (1260); Device Inoperable (1663); Low impedance (2285); Device Displays Incorrect Message (2591)

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

Event Date 08/12/2015

Event Type  malfunction  

Event 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
• 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: 6262399
• MDR Text Key: 65218679
• Report Number: 3005025697-2017-00003
• 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,s
• Reporter Occupation: Physical Therapist
• Type of Report: Initial
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2011
• 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: BECOLIDE PUFFER 1 PUFF; BIAXIG 300 MG; ESOMEPRAZOLE MAGNESIUM 40 MG; PARACETAMOL 1000 MG; RABEPRAZOLE20 MG; SIMVASTATIN 20 MG; VENTOLIN PUFFER 1 PUFF
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 94