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Signals from Device Events
January 2020

Signals is a quarterly medical device adverse events newsletter.


DEVICE SPOTLIGHT
                        
Spinal Cord Stimulators
NOTE: The following Adverse Event data was extracted from the FDA MAUDE database using Device Events, a cloud-based software service that extracts, consolidates and provides comprehensive reports and trends on the millions of medical device adverse event reports that have been submitted to the FDA. 
DEVICE NAME: 
     SPINAL CORD STIMULATOR
     PRODUCT CODE:  LGW
 
ADVERSE EVENTS RECEIVED BY THE FDA FROM:
  • TOTAL....................179,996
  • INJURY...................118,283
  • MALFUNCTION........60,376
  • DEATH...........................763
  • OTHER...........................574      

Top 3 Manufacturers of Spinal Cord Stimulators Reporting Adverse Events

Spinal Cord Stimulators - Adverse Event Trend - Deaths

Spinal Cord Stimulators - Adverse Event Trend - Injury



Spinal Cord Stimulators - Adverse Event Trend - Malfunctions

IN THE NEWS

 
Spinal-cord stimulators help some patients, injure others
Patients report that they have been shocked or burned or have suffered spinal-cord nerve damage ranging from muscle weakness to paraplegia, FDA data shows.
November 28, 2018 - NBC News Report - WEST COLUMBIA, South Carolina — Desperate for relief after years of agony, Jim Taft listened intently as his pain management doctor described a medical device that could change his life.  It wouldn't fix the nerve damage in his mangled right arm, Taft and his wife recalled the doctor saying, but a spinal-cord stimulator would cloak his pain, making him "good as new."
 
Taft's stimulator failed soon after it was surgically implanted. After an operation to repair it, he said, the device shocked him so many times that he couldn't sleep and even fell down a flight of stairs. Today, the 45-year-old Taft is virtually paralyzed, barely able to get to the bathroom by himself.
"I thought I would have a wonderful life," Taft said. "But look at me."

For years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors push them as a safe antidote to the opioid crisis in the U.S. and as a treatment for an aging population in need of pain relief. 
View Full Article
 
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Spinal-cord stimulators rank 3rd in injury reports to FDA over past decade
November 26, 2018 - BECKER'S ASC REVIEW - Spinal-cord stimulators accounted for the third-highest number of medical device injury reports to the Food and Drug Administration since 2008, an Associated Press investigation found.

The AP investigated the global medical devices industry for nearly a year in partnership with NBC, the International Consortium of Investigative Journalists and more than 50 other media organizations around the world. They analyzed millions of medical records, recall notices and product safety warnings and conducted multiple interviews.

Here's what you should know:
1. The FDA tracks 4,000 types of medical devices, and only metal hip replacements and insulin pumps had more injury reports than spinal-cord stimulators. The number of spinal-cord stimulator reports are "disproportionately higher" compared to hip implants, which are more common, according to the investigation.   View Full Article
 
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Complications of Spinal Cord Stimulator Implantation
August 2019 - ASRA - American Society of Regional Anesthesia and Pain Medicine - Pain is an important factor in determining a patient’s quality of life. Recent years have seen a trend toward nonpharmacologic treatment of pain, which has occurred secondary to the increasing evidence of the lack of efficacy of opiates and other pain medications. Current Centers for Disease Control and Prevention (CDC) guidelines for pain management recommend nonpharmacologic and non-opiate pharmacologic management of chronic pain symptoms.[1] Neuromodulation, specifically spinal cord stimulation (SCS), presents a viable option for nonpharmacologic management of a subset of patients suffering from chronic pain. However, as with any treatment modality, associated risks accompany the benefits of SCS.
 
Complications, however, are estimated to range from 30% - 40%
and can be divided into two categories: device-related failure or biologic factors
View Full Article
 
ABOUT DEVICE EVENTS
Device Events LLC is a Pennsylvania-based company that provides a cloud-based software service that extracts, consolidates and provides clear and comprehensive metrics and reports on the millions of complex medical device adverse event reports (MDRs) and recalls that have been filed with the FDA.
 · Our service helps all organizations associated with healthcare by providing them with clear, comprehensive and cost effective access to the most up to date information on problem medical devices. ·  We are committed to making information on problem devices easily accessible to our customers so they can improve health outcomes and patient safety while reducing risk for their organizations.  For more information visit our website at www.deviceevents.com
Copyright © 2020 Device Events, Inc, All rights reserved.


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