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

Model Number 2200P-47E

Device Problems High impedance (1291); Device Inoperable (1663); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 07/25/2017

Event Type  malfunction  

Event Description

This patient experienced a flashing red light on their device approximately (b)(6) 2017.On (b)(6) 2017, the site reported that they could not restart therapy.The clinician programmer indicated error code 25 (too many therapy retries).Impedance testing indicated high posterior tip to ring and anterior tip to posterior tip impedance measurements.Device remains implanted, but therapy is not being delivered.

Manufacturer Narrative

Engineering was unable to confirm the customers complaint as the rnr passed the final functional test and due to the condition of the leads after removal surgery, they were not able to be investigated.

Event Description

This patient experienced a flashing red light on their device approximately (b)(6), 2017.On (b)(6) 2017, the site reported that they could not restart therapy.The clinician programmer indicated error code 25 (too many therapy retries).Impedance testing indicated high posterior tip to ring and anterior tip to posterior tip impedance measurements.

• Brand Name: MAESTRO RECHARGABLE SYSTEM
• Type of Device: POSTERIOR LEAD
• Manufacturer (Section D): ENTEROMEDICS, INC; 2800 patton road; saint paul MN 55113
• Manufacturer (Section G): ENTEROMEDICS; 2800 patton road; saint paul MN 55116
• Manufacturer Contact: randy hoyt ; 2800 patton road; saint paul, MN 55113 ; 6517892671
• MDR Report Key: 6814574
• MDR Text Key: 83747340
• Report Number: 3005025697-2017-00019
• Device Sequence Number: 1
• Product Code: PIM
• UDI-Device Identifier: 00857334004293
• UDI-Public: 00857334004293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

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: 12/01/2017
• Device Model Number: 2200P-47E
• Device Catalogue Number: 2200P-47E
• Device Lot Number: CR-01897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 113