MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Nausea (1970); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consume regarding a patient with an implantable neurostimulator (ins).It was reported her device was not working.The patient was transferred to patient services on (b)(6).The patient reported the va took so long to get her device to turn on, it was off from (b)(6) 2016 until (b)(6) 2018.Patient services asked the patient to clarify the device being off and there was no device allegation, just the va assistance.It was reported the patient had increased nausea.The patient noted they had a motor vehicle accident but doubted it was related.The patient noted the increased nausea began in (b)(6) 2018.Additional information from the consumer regarding the patient reported they had been trying to find someone in her area to take care of her stimulator, there were no healthcare professionals (hcp) in florida expect one that did not take her insurance.The patient noted she called her hcp on (b)(6).The patient noted she was having problems with her stimulator.The patient noted she did not feel good, she had a return of symptoms, nausea, vomiting, and had accidents on herself.The patient noted it was not working or something.The patient noted she was in bed and couldn¿t function and it was messing with her blood pressure.There were no further complications that have been reported as a result of this event.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8236423
• MDR Text Key: 132821815
• Report Number: 3007566237-2019-00120
• Device Sequence Number: 1
• Product Code: LNQ
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2019
• 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
• Patient Age: 57 YR