MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are:product id: neu_enterra_ins, product type: implantable neurostimulator.

Event Description

A manufacturing representative (rep) reported on behalf of a healthcare provider (hcp) that the patient has had intermittent success with the device since implant.They seemed to do well for a couple of months and then called the office with increased symptoms.They adjusted the device and again they would do well for a couple of months and then would call with the same issue.The hcp stated that the patient's issues were more psychiatric.It was unclear if there were any external factors related to the event.The issue was noted as not being resolved at the time of the report.Additional information from the rep reported the patient was still not having a good response despite multiple programming adjustments.They had a period of about one year where they did really well.They rep just saw the patient on the day of the report and their impedance was at 816 after seeing readings of 959 and 864 a few minutes prior.There were no actions taken related to the event.The cause of the impedances at 816, 959 and 864 were unknown and the issue was not resolved at the time of the report.The implantable neurostimulator (ins) was indicated for gastric stimulation, gastrointestinal/pelvic floor.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6353022
• MDR Text Key: 68143240
• Report Number: 3004209178-2017-04449
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2017
• Date Device Manufactured: 12/23/2014
• 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