Health product recall

Activa PC+S Implantable Neurostimulator (INS) (2018-08-29)

Starting date:
August 29, 2018
Posting date:
September 28, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-67826

Affected products

Activa PC+S Implantable Neurostimulator (INS)

Reason

Manufacturer identified anomaly in the Activa PC+S firmware. This anomaly can result in a Model 37604 Activa PC+S Implantable Neurostimulator (INS) that cannot communicate with programming instruments, such as the Model 37642 patient programmer or Model 8840 clinician programmer. The issue also affects Activa PC+S devices that have been updated with the investigational nexus-e firmware.

Affected products

Activa PC+S Implantable Neurostimulator (INS)

Lot or serial number

NKM734554H
NKM734555H
NKM734557H
NKM745236H
NKM747039H
NKM747041H
NKM747050H
NKM747866H
NKM747867H
NKM751631H

Model or catalog number

37604

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