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.
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.
Reasons the product is recalled
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.
The M8 and S8 Lead Adaptors are correctly noted as MR unsafe in the MRI manual.
The hazards to consumers
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.
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 consumers should 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.
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.