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POCKET ADAPTOR KIT FOR DEEP BRAIN STIMULATION (2016-06-23)
- Starting date:
- June 23, 2016
- Posting date:
- July 19, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-59374
Affected products
A. POCKET ADAPTOR KIT FOR DEEP BRAIN STIMULATION
Reason
Notification communicates recent results from returned product analysis of Medtronic Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors with reports of high impedances, and reinforces device labeling specific to the handling of pocket adaptors and system integrity checking during implant procedures.
Medtronic has identified sixteen (16) DBS pocket adaptors that were returned for high impedance measurements and where subsequent Medtronic analysis identified conductor wire fractures in close proximity to the location where the adaptor wire exits the neurostimulator connector block.
Notification raises awareness of current product labeling that could reduce potential for pocket adaptor conductor wire fractures or increase detection of an issue during the implant procedure.
Affected products
A. POCKET ADAPTOR KIT FOR DEEP BRAIN STIMULATION
Lot or serial number
All lots
Model or catalog number
- 64001
- 64002
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES