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ST. JUDE MEDICAL, INC. (CRM-KISTA)

Manufacturer adverse-event records for ST. JUDE MEDICAL, INC. come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2015–2016 · thin-book · elevated Death-code · balanced

Volume signature

ST. JUDE MEDICAL, INC. is a thinner MAUDE footprint

ST. JUDE MEDICAL, INC. (CRM-KISTA) accounts for 5,323 FDA MAUDE reports (#362 of 434, thin-book tercile). Death-coded event_type share is 1.62% (elevated); Injury share 48.3% (balanced).

What the volume reading shows for ST. JUDE MEDICAL, INC. (CRM-KISTA)

The standout signal for ST. JUDE MEDICAL, INC. (CRM-KISTA) is filing volume: 5,323 adverse-event reports in FDA MAUDE (#362 of 434, thin-book). Death-coded event_type share sits at 1.62% (elevated).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 12 device types, led in this extract by Malfunction at 2,667 (50.1% of event_type total). Peak single-year volume reaches 3,437 reports across 2 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,323
Total Reports
86
Event-type Death
2,570
Injury Reports
12
Device Types

Event Types

Malfunction 2,667 (50.1%)
Injury 2,570 (48.3%)
Death 86 (1.6%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 3,200 (58.6%)
1,889 (34.6%)
Hospitalization 141 (2.6%)
R 132 (2.4%)
Death 83 (1.5%)
Other 6 (0.1%)
H 2 (0.0%)
Congenital Anomaly 2 (0.0%)
L 1 (0.0%)
Disability 1 (0.0%)
Life Threatening 1 (0.0%)

Devices (12)

Device Reports
Permanent Defibrillator Electrodes 1,663
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes 914
Implantable Cardioverter Defibrillator (Non-Crt) 824
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) 799
Implantable Pulse Generator, Pacemaker (Non-Crt) 489
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode 442
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) 83
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) 71
Catheter, Percutaneous 19
Transmitters And Receivers, Physiological Signal, Radiofrequency 9
Programmer, Pacemaker 6
Permanent Pacemaker Electrode 4

Yearly Trend

15
2015: 3,437
16
2016: 1,886

Read our methodology - how this data is sourced, computed, and verified.