StealthStation S7 & Cranial Software system (2019-08-19)

Starting date:

August 19, 2019

Posting date:

September 12, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70959

Last updated: 2019-09-12

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  Reason
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  Affected products

Affected Products

1. StealthStation S7 system
2. StealthStation S7 Cranial Software

Reason

Medtronic has received reports of entry point and lead placement inaccuracies during deep brain stimulation (DBS) lead implantation procedures using nexframe and the Stealthstation auto-registration feature with the O-arm imaging system. This notification is to inform customers of the potential of this type of inaccuracy and to recommend actions that may prevent it from occurring.

Deep brain stimulation (DBS) lead implantation procedures using nexframe and the auto-registration feature with the O-arm imaging system are characterized as not having implanted bone fiducials for manual patient registration and not having rigid head fixation (the patient's head is not pinned), which can lead to undetected patient motion during the O-arm registration scan.

Investigation has shown that minor patient movement may not be initially detected by the user or the software during the O-arm auto-registration scan and could have caused the observed inaccuracies. Potential sources of movement may include: respiration motion, tremor, or other voluntary/involuntary motion. The undetected movement could lead to risks for the patient, including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging.

Affected products