Greatbatch Ltd · Permanent Pacemaker Electrode (Lead) · First cleared Oct 2018
Total Reports
358
Reports (30d)
8
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Lead Explanted Due to Performance Issue
adverse, effects, form, additional adverse, explanted
3
reports
High Out of Range Impedance in Ventricular Lead
adverse, impedance, effects, range, service
1
reports
ICD System Explanted Due to Infection
implantable cardioverter, icd, infection, cardioverter defibrillator, defibrillator icd
1
reports
Lead Capped Due to Performance Issue
lead capped, effects, form, service, additional adverse
1
reports
Rising Impedance in Leads
impedance, fracture, thresholds, reported lead, high thresholds
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Minimally invasive implantation of the myopore sutureless myocardial pacing lead.
Ceresa F, et al. · 2012
A Novel Approach for Repetitive Dislocation of Transvenous Left Ventricular Leads During Cardiac Resynchronization Therapy Implantation by the Loop Technique.
Wu HY, et al. · 2022
Thoracoscopic Implantation of Epicardial Left Ventricular Lead for Cardiac Resynchronization Therapy
Hye Ree Kim, et al. · Journal of Cardiovascular Development and Disease · 2022
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. 1 active signal detected right now.
Get Early AccessUnderstanding this data
