Additional Information

Indications For Use
The NeuroControl VOCARE Bladder System is indicated for the treatment of patients who have clinically complete spinal cord lesions (ASIA classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.

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Contraindications
The Neurocontrol VOCARE Bladder System is contraindicated for patients with the following characteristics

• poor or inadequate bladder reflexes
• active or recurrent pressure ulcers
• active sepsis
• implanted cardiac pacemaker

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Warnings
The NeuroControl VOCARE Bladder System may only be prescribed, implanted, or adjusted by clinicians who have been trained and certified in its implementation and use.

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Magnetic Resonance Imaging (MRI)
Do no expose patients to MRI. There are potential effects of induced currents and radio frequency heating of the VOCARE Bladder System when exposed to magnetic fields and radio frequency fields associated with MRI systems which may result in patient injury.

Precautions

• X-rays, diagnostic ultrasound: X-ray imaging and diagnostic ultrasound have not been reported to affect the function of the Implantable Receiver-Stimulator or Extradural Electrodes. However, the implantable components may obscure the view of other anatomic structures.
• Therapeutic ultrasound, therapeutic diathermy, and microwave therapy:Therapeutic ultrasound, therapeutic diathermy, and microwave therapy should not be performed over the area of the Implantable Receiver-Stimulator or Extradural Electrodes as it may damage the VOCARE Bladder System.
• Electrocautery:Do no touch the Implantable Components of the VOCARE Bladder System with electrocautery instruments. Do not use electrocautery within 1 cm of the electrode metal contacts.
• Antibiotic prophylaxis:Standard antibiotic prophylaxis for patients with an implant should be utilized to protect the patient when invasive procedures (e.g. oral surgery) are performed.
• Drug Interactions: Anticholinergic medications, or other medications which reduce the contraction of smooth muscle, may reduce the strength of bladder contraction achieved using the VOCARE Bladder System. Anticholinergic medications should be discontinued at least three days prior to evaluating patients of the VOCARE Bladder System and prior to implantation surgery so that bladder reflexes and response to electrical stimulation can be accurately evaluated. In addition, long-acting neuromuscular blocking agents must not be used during surgery.
• Prior Procedures (such as bladder neck surgery or bladder augmentation) or conditions (such as severe urethral damage, stricture, or erosion) may affect patient suitability for the VOCARE Bladder System or clinical outcome. Patients with bladder augmentation may not be candidates for this procedure unless they can still achieve appropriate bladder pressures through reflex contractions. Patients should be thoroughly evaluated and counseled regarding the effect of any prior procedures or conditions.
• Post-operative Incontinence may occur following posterior rhizotomy, which is typically performed in conjunction with implantation of the VOCARE Bladder System. While rhizotomy generally abolishes reflex incontinence, some patients may still experience stress incontinence. Patients should be evaluated for open bladder neck pre-operatively and counseled regarding the factors that may increase the risk of stress incontinence.
• Bowel Motility may be affected by the rhizotomy procedure and by use of the VOCARE Bladder System. Patients should be advised that the rhizotomy may decrease the response to suppositories and digital stimulation of the rectum. Conversely, use of the VOCARE Bladder System for bladder management may affect bowel motility. Patients may need to adjust the frequency and/or method of their bowel management routine postoperatively.
• The Rhizotomy Procedure typically performed in conjunction with implantation of the VOCARE Bladder System may cause loss of erectile function and ejaculation in men who had those responses before surgery.
• Spinal Instability may result from the laminectomies required during implantation and rhizotomy surgery. Patients should be evaluated carefully for added risk factors, such as significant osteoporosis or scoliosis.
• Studies Have Not Been Conducted on the use of the NeuroControl VOCARE Bladder System in pregnant women.
• Post-Operatively, the patient should be advised to check the condition of his or her skin over the VOCARE Bladder System Receiver-Stimulator and leads daily for signs of redness, swelling, or breakdown. If skin breakdown becomes apparent, patients should contact their clinician immediately. The clinician should treat the infection aggressively, taking into consideration the extra risk presented by the presence of the implanted materials.
• Unintended Stimulation: While there have been n no reports of VOCARE Bladder System activation or malfunction due to electromagnetic interference (such as retail anti-theft detectors, airport metal detectors, or other electronic devices), testing has not been conducted to rule out the possibility of this occurring. Patients should be advised to notify the clinician if they experience unintended stimulation when the VOCARE Bladder System is not in use. If possible patients should note when and where the stimulation occurred.
• Keep it dry: The user should avoid getting the external components, cables, and attachments of the VOCARE Bladder System wet.
• The patient and caregiver should be advised to inspect the external cables and connectors daily for fraying or damage and replace components when necessary.
• To avoid possible interference, patients with electric wheelchairs should be advised to turn off their wheelchair controller prior to turning on the VOCARE Bladder System External Controller.
• External Defibrillation: The effect of external defibrillation on the VOCARE Bladder System is unknown.
• Patients should be advised to turn off the VOCARE Bladder System External Controller when not in use. The External Transmitter can become hot if the VOCARE Bladder System is left on for extended periods of time.

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