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

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  Reason
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  Affected products

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