ABBOTT (ST. JUDE MEDICAL) · Permanent Defibrillator Electrode (Lead) · First cleared Oct 1998 · 6 device variants grouped
Total Reports
3,882
Reports (30d)
36
Active Signals
5
Open Recalls
0
What the reports describe · Claripulse analysis
Failed Implant Attempt Due to Helix Issue
lead implanted, stable, new lead, implant procedure, helix
19
reports
Noise Oversensing Observed in Clinic Follow-Up
resolve event, observed right, patient stable, clinic follow, clinic
8
reports
Oversensing Noise with No Intervention
oversensing noise, patient stable, intervention, consequences, intervention performed
6
reports
Dislodged Lead Confirmed by X-Ray
replaced patient, patient stable, stable, patient presented, capture
5
reports
Explanted ICD Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
5
reports
Remote Monitoring Noise Oversensing
intervention performed, patient condition, condition, remote, intervention
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Prevalence and management of electrical lead abnormalities in cardiac implantable electronic device leads.
Roberts H, et al. · 2023
[<sup>68</sup>Ga]Ga-DOTA-TOC Synthesis by a Cassette Developer System with [<sup>68</sup>Ga]GaCl<sub>3</sub> from Cyclotron using Liquid Target: An Italian Experience.
Cossandi M, et al. · 2025
Inhibition of ventricular output in a dual chamber pacemaker with normal pacing and sensing parameters: What is the mechanism?
Bera D, et al. · 2021
Medial subclavicular musculotendinous complex and insulation break: Rare cause of late pacemaker lead malfunction.
Bhattacharyya PJ, et al. · 2015
DDD pacemaker for severe heart failure-alternate to CRT.
Krishnamani NC. · 2016
Citations indexed from PubMed.
Keep exploring
CAPSUREFIX Novus
MEDTRONIC, INC. · 43,528 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 36,855 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 36,335 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 27,017 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,619 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,450 reports
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 5 active signals detected right now.
Get Early AccessUnderstanding this data
