📊 Evidence-Based Reference
Permanent Pacing Lead Model Rxbj Series
Oscor Medical
Summary: The permanent pacing lead model RXBJ series by Oscor Medical is used for cardiac pacing. It is FDA 510k cleared and linked to 10 studies. Key findings include its use in various pacing techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K882462 ↗
Decision Date ?
October 28, 1988
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The permanent pacing lead model RXBJ series was cleared through the FDA 510k pathway on October 28, 1988. Manufactured by Oscor Medical, it is classified as a Class 3 device.
What It Is
The permanent pacing lead model RXBJ series is designed for cardiac pacing, providing electrical stimulation to maintain heart rhythm. It is used in conjunction with pacemakers for patients with arrhythmias.
FDA-Cleared Indications
- Cardiac pacing when electrical stimulation is clinically indicated.
- Use as a permanent pacing lead with a compatible implanted pacemaker system.
Clinical Applications
- Permanent transvenous cardiac pacing.
- Connection between an implanted pacemaker generator and the intended cardiac chamber.
- Pacing support for patients with clinically significant bradyarrhythmias when a permanent pacemaker is indicated.
Evidence Summary
The literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 2015 and 2023. These studies explore different pacing techniques and patient outcomes.
Reported Outcomes
Published studies report that the RXBJ series leads are effective in maintaining cardiac rhythm in patients with arrhythmias. They have been used successfully in both adult and pediatric populations, with outcomes showing improved heart function and patient quality of life.
Safety Profile
Reported complications include potential lead dislodgement and infection at the implantation site. Some studies noted challenges in lead placement, particularly in pediatric patients due to anatomical considerations.
Evidence Limitations
Evidence gaps include a lack of long-term outcome data and limited studies on specific patient subgroups. Further research is needed to explore the device's performance in diverse clinical settings and its long-term safety profile.
Practical Considerations
- The available record does not specify lead length, diameter, fixation mechanism, polarity, or cardiac-chamber configuration; clinicians should verify the original labeling and current device documentation.
- The lead must be compatible with the selected pacemaker generator, connector standard, and pacing system.
- Implantation requires fluoroscopic or other appropriate imaging guidance, sterile technique, and cardiac rhythm monitoring.
- MRI eligibility cannot be determined from this record. Do not assume the lead is MRI-conditional; confirm the complete implanted system and manufacturer labeling.
- Potential contraindications and precautions include active infection, unsuitable venous access, inability to safely position the lead, and patient-specific procedural or anesthesia risks.
Frequently Asked Questions
What are the clinical indications for permanent pacing lead model RXBJ series?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias such as atrioventricular block and sick sinus syndrome.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of cardiac rhythm and improved heart function in both adult and pediatric patients.
What complications have been reported?
Safety data indicates potential complications such as lead dislodgement and infection at the implantation site.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.