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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
- Synergy Neurostimulator dual-channel Itrel IPG for spinal cord stimulation
- Restore multi-program rechargeable Neurostimulator - main unit
- Restore multi-program Neurostimulator - low impedance lead kit
- PrimeAdvanced multi-program Neurostimulator - main unit
- RestoreAdvanced multi-program Neurostimulator - main unit
- RestoreAdvanced multi-program Neurostimulator - patient programmer
- Specify 5-6-5 lead kit
- RestoreUltra multi-program Neurostimulator system - main unit
- ITREL 3 system implantable pulse generator
- Specify lead
- Pisces Quad Compact Lead
- Resume II Lead
- Pisces Quad Plus
- Synergy Versitrel IPG
- Resume TL Lead
- Specify 2x8 Lead kit
- Restoresensor multi-program rechargeable Neurostimulator
- Restoresensor multi-program rechargeable Neurostimulator - patient programmer
- ITREL 4 system - implantable Neurostimulator (INS.
- Patient programmer
- RestoreUltra surescan MRI Neurostimulator
- RestoreAdvanced surescan MRI Neurostimulator
- RestoreSensor surescan MRI Neurostimulator
- PrimeAdvanced surescan MRI Neurostimulator
- Patient programmer (97740)
- Vectris surescan MRI leads
- 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