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

Model Number 37800

Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/15/2021

Event Type  Injury  

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient (b)(6) 2021 visit to request removal.Patient believes that the battery has been dead since (b)(6) 2021.Last seen (b)(6) 2020.She has been doing well with dead battery and states her symptoms of nausea and vomiting were never improved with the pacer despite high settings.She's able to eat, has rare nausea, weight is stable, and symptoms are controlled.Removal of her implant is scheduled for (b)(6) 2022.No further complications were reported at this time.

Manufacturer Narrative

Other applicable components are: product id :435135 serial# (b)(4) implanted: (b)(6) 2011 explanted: product type lead product id :435135 serial# (b)(4) implanted: (b)(6) 2011.Product type lead other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4) ; product id: 435135, serial/lot #: (b)(4), ubd: (b)(6) 2012, udi#: (b)(4).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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13082573
• MDR Text Key: 285558164
• Report Number: 3004209178-2021-19023
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Date Device Manufactured: 03/20/2019
• 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
• Treatment: .
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female