July 1, 1992Pacing and Clinical Electrophysiology
A Multicenter Experience with a Bipolar Tined Polyurethane Ventricular Lead
Key result
The Medtronic 4012 pacing lead demonstrated an unacceptable failure rate, reaching a 20.9% probability of failure at 6 years after implantation.
Why the study?
What is the failure rate and clinical manifestation of failure for the Medtronic 4012 polyurethane bipolar tined pacing lead?
Population
1,190 Medtronic 4012 pacing leads implanted in patients across 6 centers in the United States and Canada.
Design
Cohort
Follow-up
6 years
Authors
Discussion
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Member takes
Implication
May warrant enhanced surveillance for Medtronic 4012 leads; leaves open need for prospective validation of failure rates.
Study Design
Type
Cohort (n=1,190)
Multicenter
Yes
Structured PICO
What is the failure rate and clinical manifestation of failure for the Medtronic 4012 polyurethane bipolar tined pacing lead?
P
Population
1,190 Medtronic 4012 pacing leads implanted across six centers in the United States and Canada, evaluated for lead failure over 6 years.
E
Exposure
Medtronic 4012 pacing lead (polyurethane bipolar tined ventricular lead)
O
Outcome
Probability and clinical manifestations of lead failure (specifically failures compatible with an insulation problem)safety
The Medtronic 4012 pacing lead has an unacceptably high failure rate of 20.9% at 6 years due to insulation problems, prompting recommendations for prophylactic replacement in pacemaker-dependent patients.
Cite This Study
Hayes et al. (1992) conducted a cohort in Patients requiring ventricular pacing (n=1,190). Medtronic 4012 pacing lead was evaluated on Probability of lead failure compatible with an insulation problem. The Medtronic 4012 pacing lead demonstrated an unacceptable failure rate, reaching a 20.9% probability of failure at 6 years after implantation.