MAUDE Adverse Event Report: MEDTRONIC SECURA DR MEDTRONIC ICD SECURA; DEFIBRILLATOR

Model Number PUG216804H

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems Memory Loss/Impairment (1958); Pain (1994); Pneumonia (2011); Sepsis (2067); Tachycardia (2095); Vomiting (2144); Weakness (2145); Confusion/ Disorientation (2553); Multiple Organ Failure (3261)

Event Date 04/14/2017

Event Type  Injury  

Event Description

Early in the year my mother felt very ill and started having tachycardia almost daily, she was vomiting a lot and everything she tried to eat would come back up.I took her to the emergency room because i could physically see her heart beating uncontrollably out of her chest.The hospital could not get her heart rate under control and it was obvious her medtronic secura pacemaker defibrillator was not functioning properly to regulate her heart rate.The hospital administered medication to slow her heart rate but the medication was unsuccessful.The hospital then made the decision to manually shock her heart back into a sinus rhythm.They then sent her home after about 30 minutes.Her health continued to decline and not long after she was hospitalized in the icu where she was in critical condition, her body was septic, her organs were shutting down and she was diagnosed with pneumonia and the flu as well.During this time we reported to the doctors that we believed her pacemaker defibrillator was not functioning properly because we could hear an alarm like noise radiating from the implanted device.The doctors tested the device and said the battery showed good and nothing could be done until it read on the computer that it was time to change the device.My mother's health continued to decline and many more trips to the hospital when many life threatening episodes and hospitalization.She just was not getting any better.She was bedridden, on oxygen full-time, unable to eat and dying slowly in front of our eyes and no one seemed to care about our concerns with the device malfunctioning causing her heart to act up.Her kidneys and other organs were not functioning right due to lack of blood and oxygen.My mother went from a vibrant energetic woman to a dying woman.She was confused, forgetful and very weak.I had to give her showers and help her daily with everything.After about six months of constant e.R.Visits and hospital stays the doctors finally decided the device was malfunctioning and decided to schedule her for surgery to remove it and replace it.My father also has a medtronic pacemaker defibrillator and has started showing signs of his malfunctioning as well.He is experiencing severe fatigue, nausea and vomiting and his device is making the alarm like sound as well.I think an investigation into these devices needs to be done a.S.A.P.Before many people start dying, my mother came very close to death and only by the grace of god she is still alive.

• Brand Name: MEDTRONIC ICD SECURA
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): MEDTRONIC SECURA DR
• MDR Report Key: 7006543
• MDR Text Key: 91441683
• Report Number: MW5073161
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/30/2017
• Device Model Number: PUG216804H
• Device Catalogue Number: PJN2058166
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Weight: 64