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

Model Number 37800

Device Problems Break (1069); Material Deformation (2976)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144); Twiddlers Syndrome (4563)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 435135, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2021, product type lead.Product id 435135, serial# (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2021, product type lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 31-aug-2009, udi#: (b)(4).Product id: 435135, serial/lot #: (b)(4), ubd: 28-aug-2009, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that¿the patient reported to the emergency room (er) in (b)(6) of this year with pain, nausea and vomiting.They also ended up in the er for the same reason from (b)(6) 2021.The physician took them to the operation room (or) today and discovered the leads were knotted behind the battery and one of them had fractured.The patient decided to replace both leads.The patient stated that it looked as though the patient was a twiddler.The leads were replaced and issue resolved.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11672350
• MDR Text Key: 261676771
• Report Number: 3004209178-2021-06084
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2021
• Date Device Manufactured: 12/21/2018
• 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: 44 YR
• Patient Weight: 82