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The Medtronic Pisces Z Quad® Model 3890, Pisces Z Quad Compact™ Model 3891, and Pisces Z Quad Plus® Model 3892 Leads for Spinal Cord Stimulation (SCS) are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

The function of the Medtronic Mattrix and X-trel® Neurostimulation Systems is accomplished with a power source, extension (for X-trel only) and lead (electrode). The power source generates and controls the stimulation, which is delivered to the spinal cord via electrodes at the end of the lead. The Models 3890, 3891 and 3892 Leads are lower impedance percutaneous quadripolar, implantable leads. The proximal end provides in-line fourconductor contacts that connect to the Mattrix receiver or Medtronic extension (which connects to the X-trel receiver). The proximal ends and lead bodies of all three leads are identical. Each lead model has four platinum iridium electrodes on the distal end but with variable electrode length and spacing. The electrode spacing and electrode lengths of the Models 3890, 3891, and 3892 Leads are identical to the current Models 3487A, 3887, 3888 Leads, respectively. A radio-opaque marker band at the tip of the Model 3892 Lead enhances identification when viewed in fluoroscopy. The Models 3890, 3891 and 3892 Leads are available in lengths from 10 cm to 100 cm. The Medtronic Models 3890, 3891, and 3892 Leads are packaged, sterilized, and labeled for single use only (disposable).

The Medtronic Grip-lock™ Anchor is indicated for use to facilitate Medtronic neurological lead fixation.

The Grip-lock™ Anchor is an implantable, sterile, nonpyrogenic anchor which has been compatible with existing Metronic Neurological leads. The design is based on existing anchors (Twist-Lock Anchor) currently marketed for use with Medtronic Neurological Leads. The anchor is not pre-attached to the lead but is provided separate from the lead in a default-closed configuration. By squeezing the polysulfone wings together, the physician can slide the anchor onto the lead. Grooves in the polysulfone wings provide a location for the physician to grip the wings with rubber-shod forceps. The physician can readjust the position of the anchor by squeezing the polysulfone wings and sliding the anchor along the lead body to the desired position. Once the anchor is in the desired position the physician can suture the anchor to tissue using the suture holes of each polysulfone wing and the suture T attached to the anchor body. The gripping mechanism of the Grip-lock™ Anchor is similar to that used by the Twist-Lock Anchor currently cleared for use with spinal cord stimulation (K972906). The Medtronic Grip-lock™ Anchor has "new technological characteristics (e.g., design, materials and manufacturing processes)" from the current Medtronic Twist-Lock Anchor. The new technological characteristics are listed below: - Materials : Nitinol Band of the Grip-lock™ Anchor . The Grip-lock Anchor is made primarily of polysulfone. A nitinol band encircles the anchor and serves as the closing mechanism of the anchor. Nitinol is commonly used is the medical device industry including use in cardiac stents. - Closing mechanism of the Grip-lock " Anchor: Default closed, polysulfone wings squeezed . to open. The Grip-lock" Anchor is provided in a "default-closed" configuration and is not preattached to the lead. When placing the anchor on the lead the physician can squeeze the polysulfone wings which open the anchor and allow the anchor to be moved along the length of the lead body. The Twist-Lock Anchor is also not pre-attached to the lead. When placing the anchor the physician twists the anchor to close it on the lead body.