N'vision Application Card (2013-09-23)

Starting date:

September 23, 2013

Posting date:

February 11, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-37867

• Reason
• Affected products

Recalled products

1. N'vision Application Card 

Reason

The medical device correction includes the distribution of a new 8870 software application card, version BBR/01 (Revision B) , which provides updates to the 8840 Clinician programmer used to program Medtronic spinal cord stimulators, deep brain stimulators and the Synchromed II implantable infusion system.

For SCS and DBS therapy:

the new software provides an automatic transfer of new internal device software from the 8840 to implantable and implanted devices. This change addresses loss of stimulation caused by the exception bit behavior. This behavior is also known as error code 509. In addition, the notification provides information about the potential for over stimulation or stimulation in the wrong area under a specific set of conditions, typically related to device recovery from an over discharge.

For Synchromed II pump therapy:

the update includes correction of the issue previously communicated in the March 2012 medical device correction regarding the potential for the model  8840 N'Vision clinician programmer to display an erroneous replace by date (ERBD) "schedule to replace pump by" (date when used with the Synchromed II pump. The updated software also corrects the potential for premature low and empty reservoir alarms with the Synchromed II pump. These premature alarms are due to an incorrect calculation within the 8840 programmer software. No changes are being made to the implantable Synchromed II pump device as a result of this update.

Affected products