BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
967
Reports (30d)
12
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
High Out-of-Range Shock Impedance Measurements
measurements, crt, shock, impedance, range
7
reports
Battery Voltage Low, Data Analysis Requested
crt, battery, effects, data, voltage
4
reports
Noise and Oversensing on Atrial Channel
defibrillator crt, crt, effects, service, therapy defibrillator
3
reports
Inappropriate Therapy Delivered for Atrial Rhythm
crt, remains service, therapy, tachycardia, delivered
3
reports
Premature Battery Depletion Observed
resynchronization, cardiac resynchronization, battery, crt, resynchronization therapy
2
reports
Difficulty Interrogating CRT Device
resynchronization, defibrillator crt, crt, resynchronization therapy, therapy defibrillator
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Jul 7, 2022 · Open, Classified
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Evidence
Citations indexed from PubMed.
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