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

Model Number 2200P-47E

Device Problems Device Inoperable (1663); Low impedance (2285); Low Readings (2460)

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: neuroregulator functionality to specifications was confirmed.There was fluid in the neuroregulator port for the posterior lead.Posterior lead was damaged during the explant procedure such that functionality and conformance to specifications could not be evaluated.Review of device log data confirmed the low impedance measurements reported and low impedance of ring to ring electrodes.Review of implantation video confirmed close placement of ring electrodes, which could contribute to lower impedance measurements.

Event Description

During device implantation, initial implant impedance measurements were acceptable.During the final placement of the neuroregulator, a low impedance alarm was indicated on the posterior lead.The low impedance alarm, in accordance with intended product design, prevented initiation of therapy.Because the procedure had been completed to the point where medical adhesive covered the lead connection on the neuroregulator, both the neuroregulator and posterior lead were removed and replaced with alternate components in accordance with standard practice.Implantation of alternate components resolved the low impedance alarms.The implantation procedure completed successfully without adverse impact to the patient.Final impedance measurements were somewhat low, so the impedance amplitude setting was not lowered as typically done at implant, to ensure better impedance measurement accuracy.

• 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: lisa pritchard ; 2800 patton road; saint paul, MN 55113 ; 6517892681
• MDR Report Key: 5104219
• MDR Text Key: 26769385
• Report Number: 3005025697-2015-00001
• 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
• Report Date: 09/25/2015

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2014
• 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