Emergo Asia Pacific Pty Ltd t/as Emergo Australia — M8 and S8 Lead Adaptors

PRA number

2021/19109

Published date

Product description

M8 and S8 Lead Adaptors

Product codes: MADP2008-25(B) and SADP2008-25(B)

ARTG 199081
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - S8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological)

ARTG 204062
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - M8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological)

Used with Spinal Cord Stimulation (SCS) Systems that are neuromodulation devices designed to deliver electrical stimulation for the treatment of chronic intractable pain of the trunk and/or limbs.

What are the defects?

Certain patients who have been implanted with S8 (SADP2008-25(B)) or M8 (MADP2008-25(B)) Lead Adaptors received implant cards (patient ID cards) that incorrectly indicate the system is 'MR Conditional', systems with these lead adaptors should be identified as 'MR Unsafe'. The M8 and S8 Lead Adapters of the implanted Senza system are not MR Conditional.

The M8 and S8 Lead Adaptors are correctly noted as MR unsafe in the MRI manual.

What are the hazards?

Magnetic Resonance Imaging (MRI) poses a hazard to consumers who are implanted with S8 or M8 Lead Adaptors. Consumers with 'MR Unsafe' implants should not be scanned.

If users are unaware that the lead adaptors are 'MR Unsafe' they may provide incorrect information to medical staff and this may result in a serious injury.

What should consumers do?

Emergo Australia will directly contact implanted consumers to provide a new 'MR Unsafe' implant card.

For further information, contact Emergo Australia by phone on 02 9006 1662.

Where the product was sold

Australian Capital Territory
New South Wales
Queensland
South Australia
Tasmania
Victoria
Western Australia

Responsible regulator

Therapeutic Goods Administration is the responsible regulator for this recall.

Product category