OmniaSecure™ MRI SureScan™

Issue

The model 3930M is a transvenous DF4 lead labelled for use in the RV and left bundle branch area (LBBA). It uses a fixed helix design, so the lead must be rotated as a whole for fixation. It's design transfers torque from the connector and lead body to the distal tip, supporting deep septal placement. To support this function, the lead incorporates interlocking mechanical features between the helix and tip to ring (tr) spacer, along with an adhesive bond applied during manufacturing. The adhesive is dispensed manually in a three-step process. All returned product analysis and some initial pho returns showed inadequate adhesive coverage at the tr spacer to helix interface. Current investigation indicates that operator technique and inspection contribute to the root cause. Insufficient adhesive at the interface between the driveshaft assembly and tr spacer causes a weak bond. Torque applied during the implant procedure may cause the adhesive bond to break. The helix then can separate from the TR spacer, referred to as driveshaft separation, while maintaining the overall lead connection with the cable. If separation occurs and the lead is implanted, the helix and cable assembly are unsupported, and lead fracture may occur over time.

What you should do

• Contact the manufacturer if you require additional information.