M8 and S8 Lead Adaptors
AustraliaM8 and S8 Lead Adaptors
Reason for Recall / Hazard
TranslatedCertain 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.
Product Description & Identification
TranslatedReason / 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. 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 to 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.
Affected Products
TranslatedM8 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.
Additional Source Details
| Field | Value |
|---|---|
| Guid › #text | 9ffcc18c-f10d-4f66-8690-4934562b0424 |
| Guid › @ is Perma Link | false |
| Link | https://www.productsafety.gov.au/search-consumer-product-recalls/m8-and-s8-lead-adaptors |
| Pub Date | Sun, 27 Jun 2021 00:00:00 +0000 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsCheck the model number, serial number, and date stamp on the rating label on the back or underside of the product.
Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Australia Products).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought M8 and S8 Lead Adaptors?
Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Australia Products). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Risk Level["Pharmacy and medical products","Power supply and storage"]
- DistributionAustralia
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