PRODUCT ADVISORIES SPINAL CORD STIMULATION

 

Medtronic is committed to providing you with the highest quality products and services and ongoing support.

As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.


2016

URGENT: MEDICAL DEVICE CORRECTION – SEPTEMBER 2016

SPINAL CORD STIMULATION THERAPY: IMPORTANT INFORMATION REGARDING THE MODEL 37751 RECHARGER

Models Affected: Model 37751 Recharger, which is included in Models 37754 and 97754 Charging Systems for SCS

Description:

This notification communicates important information regarding the issue of unresponsive and beeping Model 37751 Rechargers, and provides information on how to prevent occurrence of this issue and restore functionality of the Recharger if the issue occurs. Medtronic has identified an increased number of complaints from customers involving reports of Rechargers that that are in an unresponsive error state, where the Recharger is non-functional with a blank display screen and is beeping every 5 seconds. This Recharger is used by SCS patients who are implanted with the following implantable neurostimulators:

  • Restore™ (Model 37711)
  • RestoreUltra™ (Model 37712)
  • RestoreAdvanced™ (Model 37713)
  • RestoreSensor™ (Model 37714)
  • RestoreUltra SureScan™ MRI (Model 97712)
  • RestoreAdvanved SureScan MRI (Model 97713)
  • RestoreSensor SureScan MRI (Model 97714)

Read on for detailed information related to this communication.

Urgent Medical Device Safety Notification – May 2016

Insufficient Recharging of the Medtronic RestoreSensor™ Implantable Neurostimulators.

Models affected: 37714 and 97714

Description:

This physician communication provides important information regarding reports of rapid battery depletion when a charging session was terminated prior to reaching sufficient battery voltage. When this occurs, the implanted neurostimulator depletes to an overdischarge state in one to two days rather than the typical thirty days. In an overdischarge state, the stimulation therapy is interrupted.

Read on for detailed information related to this communication.

Medical Device Correction – January 2016

Upcoming Labeling Updates for Spinal Cord Stimulation

Description:

Overview MRI Guidelines Product Advisories Product Advisories Medical Device Correction – January 2016 Upcoming Labeling Updates for Spinal Cord Stimulation The purpose of this communication is to notify physicians that labeling is being updated to clarify that the Specify™ 5-6-5 and 2x8 surgical leads are not intended for interoperative trial evaluation use (i.e., trialing/screening outside of the operating room with an external neurostimulator). Some Specify 5-6-5 and 2x8 surgical lead product labeling does not distinguish between intraoperative stimulation testing with a permanent surgical lead and interoperative trial evaluation use.

Read on for detailed information related to this communication.


2015

Urgent: Medical Device Correction – January 2015

Impact of Cycling Feature on Device Battery Longevity

Description:

This notification is associated with updates to labeling related to the cycling feature in some neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation.

Read on for detailed information related to this communication.


2014

Safety Alert – February 2014

Labeling Update for Epidural Mass Causing Spinal Cord Compression

Description:

This notification is associated with changes to the adverse event labeling for Medtronic spinal cord stimulation therapy.

Read on for detailed information related to this communication.

2014

Medical Device Correction – February 2014

Impact of Cycling Feature on Longevity and Recharge Interval

Description:

This notification is associated with corrections to labeling related to the cycling feature in some neurostimulation devices used for deep brain stimulation and spinal cord stimulation.

Read on for detailed information related to this communication.


2013

Urgent: Medical Device Correction – September 2013

Loss of Stimulation and Over Stimulation

Description:

This notification is associated with neurostimulation devices used for both deep brain stimulation and spinal cord stimulation. It provides information regarding the potential for loss of stimulation and the potential for over stimulation. Read on for detailed information.

Read on for detailed information related to this communication.