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Health product recall

Medtronic Spinal Cord Stimulation Therapy (2014-02-14)

Starting date:
February 14, 2014
Posting date:
March 21, 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-38535

Recalled Products

  1. Synergy Neurostimulator dual-channel Itrel IPG for spinal cord stimulation
  2. Restore multi-program rechargeable Neurostimulator - main unit
  3. Restore multi-program Neurostimulator - low impedance lead kit
  4. PrimeAdvanced multi-program Neurostimulator - main unit
  5. RestoreAdvanced multi-program Neurostimulator - main unit
  6. RestoreAdvanced multi-program Neurostimulator - patient programmer
  7. Specify 5-6-5 lead kit
  8. RestoreUltra multi-program Neurostimulator system - main unit
  9. ITREL 3 system implantable pulse generator
  10. Specify lead
  11. Pisces Quad Compact Lead
  12. Resume II Lead
  13. Pisces Quad Plus
  14. Synergy Versitrel IPG
  15. Resume TL Lead
  16. Specify 2x8 Lead kit
  17. Restoresensor multi-program rechargeable Neurostimulator
  18. Restoresensor multi-program rechargeable Neurostimulator - patient programmer
  19. ITREL 4 system - implantable Neurostimulator (INS.
  20. Patient programmer
  21. RestoreUltra surescan MRI Neurostimulator
  22. RestoreAdvanced surescan MRI Neurostimulator
  23. RestoreSensor surescan MRI Neurostimulator
  24. PrimeAdvanced surescan MRI Neurostimulator
  25. Patient programmer (97740)
  26. Vectris surescan MRI leads
  27. Vectris trialing leads

Reason

Purpose of this recall is to inform about changes to the adverse event labeling for Medtronic spinal cord stimulation therapy. The issue is the potential for patients to experience spinal cord compression weeks to years after implant of spinal cord stimulation (SCS) lead. Spinal cord compression can lead to neurological deficit due to the formation of reactive fibrous tissue, sometimes with an inflammatory component. the time to onset for spinal cord compression ranges from weeks to over 17 years, and may progress after lead removal.

Affected products

A.  Synergy Neurostimulator dual-channel Itrel IPG for spinal cord stimulation

Lot or serial number

7427

Model or catalog number

All lots

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

B.  Restore multi-program rechargeable Neurostimulator - main unit

Lot or serial number

37711

Model or catalog number

All lots

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

C. Restore multi-program Neurostimulator - low impedance lead kit

Lot or serial number
  • 3776
  • 3777
  • 3778
  • 3876
  • 3877
  • 3878
Model or catalog number

All lots

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

D. Primeadvanced multi-program Neurostimulator - main unit

Lot or serial number

37702

Model or catalog number

All lots

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

E.  Restoreadvanced multi-program Neurostimulator - main unit

Lot or serial number

37713

Model or catalog number

All lots

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

F.  Restoreadvanced multi-program Neurostimulator - patient programmer

Lot or serial number

37742

Model or catalog number

All lots

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

G.  Specify 5-6-5 lead kit

Lot or serial number

39565

Model or catalog number

All lots

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

H.  Restoreultra multi-program Neurostimulator system - main unit

Lot or serial number

37712

Model or catalog number

All lots

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

I.  ITREL 3 system implantable pulse generator

Lot or serial number

7425

Model or catalog number

All lots

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

J.  Specify lead

Lot or serial number
  • 3998
  • 3999
Model or catalog number

All lots

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

K. Pisces quad compact lead

Lot or serial number

3887

Model or catalog number

All lots

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

L. Resume II lead

Lot or serial number

3587A

Model or catalog number

All lots

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

M. Pisces Quad Plus

Lot or serial number
  • 3487A
  • 3888
Model or catalog number

All lots

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

N. Synergy Versitrel IPG

Lot or serial number

7427V

Model or catalog number

All lots

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

O. Resume TL lead

Lot or serial number

3986A

Model or catalog number

All lots

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

P. Specify 2x8 lead kit

Lot or serial number

39286

Model or catalog number

All lots

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

Q. Restoresensor multi-program rechargeable Neurostimulator

Lot or serial number

37714

Model or catalog number

All lots

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

R. Restoresensor multi-program rechargeable Neurostimulator-patient programmer

Lot or serial number

37744

Model or catalog number

All lots

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

S. ITREL 4 system - implantable Neurostimulator (INS.

Lot or serial number
  • 37703
  • 37704
Model or catalog number

All lots

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

T. Patient programmer

Lot or serial number

37746

Model or catalog number

All lots

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

U. Restoreultra surescan MRI Neurostimulator

Lot or serial number

97712

Model or catalog number

All lots

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

V. Restoreadvanced surescan MRI Neurostimulator

Lot or serial number

97713

Model or catalog number

All lots

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

W. Restoresensor surescan MRI Neurostimulator

Lot or serial number

97714

Model or catalog number

All lots

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

X. Primeadvanced surescan MRI Neurostimulator

Lot or serial number

97702

Model or catalog number

All lots

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

Y. Patient programmer (97740)

Lot or serial number

97740

Model or catalog number

All lots

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

Z. Vectris surescan MRI leads

Lot or serial number
  • 977A160
  • 977A175
  • 977A190
  • 977A260
  • 977A275
  • 977A290
Model or catalog number

All lots

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

AA. Vectris trialing leads

Lot or serial number
  • 977D160
  • 977D260
Model or catalog number

All lots

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