Medtronic Model 8870 N'Vision Application Card (2017-03-15)

Starting date:
March 15, 2017
Posting date:
March 17, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-62680

Affected Products

  1. PrimeAdvanced Multi-Program NeuroStimulator - N'Vision Application Card
  2. RestoreAdvanced Multi-Program Neurostimulator - N'Vision Application Card
  3. RestoreUltra Multi-Program NeuroStimulator Syst - N'Vision Application Card
  4. Activa PC INS - N'Vision Application Card
  5. Activa RC NeuroStimulator - N'Vision Application Card
  6. N'Vision Application Card
  7. RestoreSensor Multi-Program Rechargeable NeuroStimulator-N'Vision Appl Card

Reason

Medtronic is updating the Model 8870 software application card (to version BBUO1) as well as the SynchroMed Infusion System labeling to address the unintended delivery of drug during the priming bolus function. The SynchroMed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision.

The updated 8870 software card mitigates the potential for clinically relevant effects of over-delivery of unintended drug, such as respiratory depression, loss of consciousness, or death, during the full system priming bolus procedure. The therapy applications on the software card for deep brain stimulation and spinal cord stimulation remain unchanged.

This recall affects all 8870 software application cards, which are used in the 8840 N'Vision Clinical Programmers. The 8870 software application card is listed under multiple licence numbers which pertain to specific sets of devices that work together.

Affected products

A. PrimeAdvanced Multi-Program NeuroStimulator - N'Vision Application Card

Lot or serial number

All lots

Model or catalog number
  • 8870
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

B. RestoreAdvanced Multi-Program Neurostimulator - N'Vision Application Card

Lot or serial number

All lots

Model or catalog number

8870

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

C. RestoreUltra Multi-Program NeuroStimulator Syst - N'Vision Application Card

Lot or serial number

All lots

Model or catalog number

8870

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

D. Activa PC INS - N'Vision Application Card

Lot or serial number

All lots

Model or catalog number

8870

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

E. Activa RC NeuroStimulator - N'Vision Application Card

Lot or serial number

All lots

Model or catalog number

8870

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

F. N'Vision Application Card

Lot or serial number

All lots

Model or catalog number

8870

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

G. RestoreSensor Multi-Program Rechargeable NeuroStimulator-N'Vision Appl Card

Lot or serial number

All lots

Model or catalog number

8870

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES