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Health product recall

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