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Medtronic deep brain stimulation (DBS) lead kits (2017-03-23)
- Starting date:
- March 23, 2017
- Posting date:
- March 23, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-62772
Affected Products
A. Quadrapolar DBS Lead Kit
B. Kinetra Neurostimulator System
C. DBS Lead
Reason
Purpose of this recall is to provide important safety information regarding the use of the depth stop accessory provided in all Medtronic deep brain stimulation (DBS) lead kits. This notification provides information regarding a product performance issue that has been identified with this component, potential risk to patients, and actions to take regarding use of the Medtronic depth stop.
The threaded area of the depth stop does not extend close enough to the handle, thus preventing it from securing firmly onto the DBS lead during implant. This deficiency may result in the lead being implanted beyond the intended target location, which could lead to significant patient consequences.
Affected products
A. Quadrapolar DBS Lead Kit
Lot or serial number
All lots
Model or catalog number
3387
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
B. Kinetra Neurostimulator System
Lot or serial number
All lots
Model or catalog number
3387
3389
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
C. DBS Lead
Lot or serial number
All lots
Model or catalog number
3389
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES