M8 and S8 Lead Adaptors
Published 27 June 2021
Product
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.
Why it was 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.
Hazard
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.