Potential Conductor Wire Fracture
6930, 6931, 6948, 6949 Sprint Fidelis Defibrillation Leads
Original Date of Advisory:
All Model 6930, 6931, 6948, and 6949 implantable defibrillation leads
There are two primary locations where chronic conductor fractures have occurred on Sprint Fidelis leads: 1) the distal portion of the lead, affecting the anode (ring electrode) and 2) near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor. These two locations account for approximately 90% of the chronic fractures identified in Returned Product Analysis (RPA). The remaining 10% of chronic fractures occurred in the DF-1 connector leg and the proximal portion of the RV coil. High voltage conductor fractures could result in the inability to deliver defibrillation therapy. Anode or cathode conductor fractures (at either location) may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output.
Patient Management Recommendations (Updated April 2011)
The Lead Integrity Alert (LIA) provides three days advance notice prior to inappropriate therapy to 76% of patients with lead fractures1. As a result, we strongly recommend that all Sprint Fidelis patients who have the ability to upgrade to Lead Integrity Alert do so promptly. Also ensure that high voltage lead impedance alerts (maximum of 100 ohms) are programmed. When a lead fracture is suspected or confirmed, immediate patient attention is strongly recommended. Physicians should inform their patients to seek medical attention without delay if they experience unexpected shocks.
- If a Fidelis lead fracture of any type has occurred,we recommend implanting a new high voltage lead with or without extraction of the Fidelis lead.
- In patients with normal device function and no manifestation of lead fracture, no action is recommended. The risk of prophylactic intervention appears to be greater than serious injury resulting from lead fracture even for pacemaker dependent patients, except in select individual patient circumstances as determined by the physician.
In the event of a device change-out or upgrade procedure, with no manifestation of lead fracture, consider the patient age and lead model data above, as well as patient life expectancy, co-morbidities, ease of extraction related to implant time, patient preference, etc., for the following options:
- Leave a properly performing lead intact.
- Implant a new ICD lead without extraction of the existing lead.
- Carefully consider all factors before prophylactic placement of a pace-sense lead. Data shows an increased risk of high voltage conductor fracture if a pace-sense conductor fracture has previously occurred. This data is available at www.medtronic.com/fidelis
- Individual patient circumstances may warrant extracting and implanting a new ICD lead. If warranted, Medtronic’s Independent Physician Quality Panel recommends the lead extraction procedure be performed by a physician with extensive lead extraction experience.2
As of March 10, 2016, of the initial implant population of 205,600 in the United States, approximately 60,700 remain implanted. According to Product Surveillance Registry results, lead survival is estimated to be 78.9% (+4.3/-4.0%) at 102 months. As the implanted population ages and the sample size increases for each time interval, the accuracy of the estimated survival probability will increase as shown by tighter confidence intervals.
Initial Affected Population
|Number of Confirmed Advisory Related Events||Estimated Remaining Active Population||
Additional information about the Sprint Fidelis lead is available at www.medtronic.com/fidelis.
279,500 Worldwide(205,600 United States)
6,684 Worldwide(4,795 United States)
82,000 Worldwide(60,700 United States)
1: Swerdlow C, Gunderson, B, et al.“Downloadable Algorithm to Reduce Inappropriate Shocks Caused by Fractures of Implantable Cardioverter-Defibrillator Leads”, Circulation, November 2008, 118: 2122-2129.
2: “Transvenous Lead Extraction: Heart Rhythm Society Expert Consensus on Facilities, Training, Indications, and Patient Management”, Heart Rhythm, Vol 6, No 7, July 2009.