BACKGROUND: We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice. OBJECTIVE: The aim of this study was to assess the performance of small-diameter Sprint Fidelis high-voltage ICD leads. METHODS: The actuarial survival of Sprint Fidelis model 6949 leads implanted at our center was compared with that of the Sprint Quattro Secure model 6947. The United States Food and Drug Administration Manufacturers and User Facility Device Experience (MAUDE) database was searched for Sprint Fidelis models. RESULTS: The survival of 583 Sprint Fidelis 6949 leads implanted at our center between September 2004 and February 2007 was significantly less than 285 Sprint Quattro Secure model 6947 leads implanted by us between November 2001 and February 2007 (P = .005). Six patients presented with Sprint Fidelis lead failure 4-23 months after implant. Five of the six patients experienced multiple inappropriate shocks associated with pace-sense conductor and coil fractures; the sixth patient had a fixation mechanism failure. The MAUDE search rendered reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%), high impedance (33%), and fracture (35%). Of 125 leads analyzed by the manufacturer, 62 involved fracture of the pace-sense conductor or coil and the high-voltage (defibrillation) conductor. CONCLUSIONS: The Sprint Fidelis high-voltage lead appears to be prone to early failure. Its use should be limited until the failure mechanism is identified and corrected. Patients should be evaluated quarterly, and automatic lead test features should be enabled. While more data are needed, routine prophylactic replacement of intact, normally functioning Sprint Fidelis leads does not appear justified.
BACKGROUND: We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice. OBJECTIVE: The aim of this study was to assess the performance of small-diameter Sprint Fidelis high-voltage ICD leads. METHODS: The actuarial survival of Sprint Fidelis model 6949 leads implanted at our center was compared with that of the Sprint Quattro Secure model 6947. The United States Food and Drug Administration Manufacturers and User Facility Device Experience (MAUDE) database was searched for Sprint Fidelis models. RESULTS: The survival of 583 Sprint Fidelis 6949 leads implanted at our center between September 2004 and February 2007 was significantly less than 285 Sprint Quattro Secure model 6947 leads implanted by us between November 2001 and February 2007 (P = .005). Six patients presented with Sprint Fidelis lead failure 4-23 months after implant. Five of the six patients experienced multiple inappropriate shocks associated with pace-sense conductor and coil fractures; the sixth patient had a fixation mechanism failure. The MAUDE search rendered reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%), high impedance (33%), and fracture (35%). Of 125 leads analyzed by the manufacturer, 62 involved fracture of the pace-sense conductor or coil and the high-voltage (defibrillation) conductor. CONCLUSIONS: The Sprint Fidelis high-voltage lead appears to be prone to early failure. Its use should be limited until the failure mechanism is identified and corrected. Patients should be evaluated quarterly, and automatic lead test features should be enabled. While more data are needed, routine prophylactic replacement of intact, normally functioning Sprint Fidelis leads does not appear justified.
Authors: Jay Sengupta; Arthur C Kendig; Marlene Goormastic; Eui-Seock Hwang; Elizabeth A Ching; Roy Chung; Bruce D Lindsay; Patrick J Tchou; Bruce L Wilkoff; Mark J Niebauer; David O Martin; Niraj Varma; Oussama Wazni; Walid Saliba; Mohamed Kanj; Mandeep Bhargava; Thomas Dresing; Tyler Taigen; Christopher Ingelmo; Mohamed Bassiouny; Edmond M Cronin; Bradley Wilsmore; John Rickard; Mina K Chung Journal: Heart Rhythm Date: 2012-07-03 Impact factor: 6.343
Authors: Christian G Wollmann; Dirk Böcker; Andreas Löher; Hans H Scheld; Günter Breithardt; Rainer Gradaus Journal: Herzschrittmacherther Elektrophysiol Date: 2009-02-11
Authors: Frederic S Resnic; Arjun Majithia; Sanket S Dhruva; Henry Ssemaganda; Susan Robbins; Danica Marinac-Dabic; Kathleen Hewitt; Lucila Ohno-Machado; Matthew R Reynolds; Michael E Matheny Journal: Circ Cardiovasc Qual Outcomes Date: 2020-04-14
Authors: Amit Kumar; Michael E Matheny; Kalon K L Ho; Robert W Yeh; Thomas C Piemonte; Howard Waldman; Pinak B Shah; Richard Cope; Sharon-Lise T Normand; Sharon Donnelly; Susan Robbins; Frederic S Resnic Journal: Circ Cardiovasc Qual Outcomes Date: 2014-12-09