PlainHospital

ABBOTT MEDICAL (CRM-SYLMAR)

Manufacturer adverse-event records for ABBOTT MEDICAL 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 · 2007–2026 · mid-book · elevated Death-code · balanced

Death-code intensity

ABBOTT MEDICAL carries an elevated Death-code share

Death-coded event_type rows are 179 of 8,537 (2.10% · elevated tercile among 434 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for ABBOTT MEDICAL (CRM-SYLMAR)

The standout signal for ABBOTT MEDICAL (CRM-SYLMAR) is Death-code intensity: 2.10% of 8,537 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for ABBOTT MEDICAL. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 18 device types, led in this extract by Malfunction at 4,912 (57.5% of event_type total). Peak single-year volume reaches 8,535 reports across 3 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

8,537
Total Reports
179
Event-type Death
3,446
Injury Reports
18
Device Types

Event Types

Malfunction 4,912 (57.5%)
Injury 3,446 (40.4%)
Death 179 (2.1%)

Patient Outcomes

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

4,147 (56.2%)
Required Intervention 2,562 (34.7%)
Other 244 (3.3%)
Death 159 (2.2%)
R 102 (1.4%)
L 44 (0.6%)
O 41 (0.6%)
Life Threatening 40 (0.5%)
Hospitalization 19 (0.3%)
D 12 (0.2%)
H 6 (0.1%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Devices (18)

Device Reports
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes 2,594
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) 1,822
Leadless Pacemaker 1,089
Permanent Defibrillator Electrodes 972
Implantable Pulse Generator, Pacemaker (Non-Crt) 756
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) 461
Pulse Generator, Permanent, Implantable 334
Implantable Cardioverter Defibrillator (Non-Crt) 286
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode 81
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) 69
Implantable Pacemaker Pulse-Generator 33
Introducer, Catheter 16
Pacemaker/Icd/Crt Non-Implanted Components 10
Permanent Pacemaker Electrode 7
Device, Percutaneous Retrieval 3
Pulse-Generator, Single Chamber, Sensor Driven, Implantable 2
Catheter, Percutaneous 1
Pacemaker Lead Adaptor 1

Yearly Trend

07
2007: 1
25
2025: 1
26
2026: 8,535

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