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

Model Number 37800

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Cognitive Changes (2551)

Event Type  Death  

Manufacturer Narrative

Information references the main component of the system.Other relevant device(s) are: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a legal representative of the patient regarding a patient implanted with an implantable neurostimulator.After the patient was implanted with a stimulator on ¿(b)(6) 2016 they developed complications related to the device.The representative stated the ¿stimulator was in a defective condition and unreasonably dangerous for its intended or expected use and posed a risk of serious harm to the patient and others,¿ to which the patient was never warned about.¿due to the defective design and/or manufacturer the stimulator failed and malfunctioned and due to this the patient sustained injuries resulting in multiple harms (including physical pain, mental suffering, mental anguish, permanent injury, and permanent impairment of the power to labor and earn money), losses, and death due to complications related to the stimulator (on or about (b)(6) 2017).¿ relevant medical history includes gastric stimulation.

• 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: 7523773
• MDR Text Key: 108600107
• Report Number: 3004209178-2018-11195
• 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: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2018
• Date Device Manufactured: 09/12/2016
• 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): Death