In November 1994, Telectronics Pacing Systems issued a voluntary recall of their Accufix 330-801 and 329-701 "J"-shaped atrial pacemaker leads. To assess the integrity of the lead, 156 consecutive patients with the Accufix 330-801 atrial lead implanted underwent fluoroscopic screening. Leads were visualized in at least two orthogonal views. When identified, fractured retention wires were classified into one of four groups, depending on the degree of wire extrusion outside of the lead insulation.
Results: Of the 156 patients, 35 patients (22.4%) had a definite retention wire fracture, and an additional 13 patients (8.3%) had indeterminate leads. Neither the age of the patients, the time since lead implant, nor the site of fracture correlated with the incidence of wire fracture. When analyzed to include indeterminate leads that were re-evaluated and found to be fractured, as well as two leads that were identified as being radiographically normal but found to be fractured after extraction, the incidence of retention wire fracture is 25.6% (40 of 156 leads evaluated).
Conclusions: The incidence of retention wire fracture in the Accufix 330-801 lead is significantly higher than originally reported. Patients should be notified of the potential dangers associated with this lead. Cardiac digital fluoroscopy is an effective method of screening for wire fracture. Leads with fractured retention wires should be extracted and those with normal fluoroscopic appearance should undergo regular fluoroscopic screening.