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

Model Number 37800

Device Problems Disconnection (1171); High impedance (1291); Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id 4351-35, serial#(b)(4), product type lead.Product id 4351-35, serial# (b)(4), product type lead.

Event Description

The consumer reported that when they went to see the healthcare provider (hcp) for a follow-up/settings appointment on (b)(6) 2017, they found out the device showed "failure." it was indicated that the device was not showing up, and the hcp mentioned that they had never seen those settings or codes before.The consumer stated that the device had not even lasted two weeks.It was noted that it was showing crazy codes and there was no current.The hcp called the manufacturer representative (rep) during the appointment and determined that one of the codes meant there was a loose screw at the bottom, at the leads.The consumer provided that they were unsure if it was a loose screw causing the lead to come undone, or what exactly the issue was.The consumer indicated that they thought one lead might be overcompensating for the other lead, causing one lead to have "crazy high ratings, wonky readings," and show ing no current running at all.They inquired about what to do about the "lemon" of a stimulator.Additional information provided by the consumer via a rep indicated that the surgery performed on (b)(6) 2017 for the failure was a revision due to a disconnected wire.The consumer stated that at first they thought the device was a lemon, but believed it may be surgical.They indicated that they really were unsure what happened.The patient was scheduled for an appointment on (b)(6) 2017 to check and adjust the settings.There were no further complications reported as a result of this event.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7102163
• MDR Text Key: 94346198
• Report Number: 3004209178-2017-25694
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169360686
• UDI-Public: 00643169360686
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 12/08/2017
• Date Device Manufactured: 08/08/2015
• 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: 11 YR