PlainHospital

SORIN GROUP ITALIA S.R.L. - CRM FACILITY

Manufacturer adverse-event records for SORIN GROUP ITALIA S.R.L. - CRM FACILITY 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 · 2014–2026 · thin-book · elevated Death-code · balanced

Volume signature

SORIN GROUP ITALIA S.R.L. - CRM FACILITY is a thinner MAUDE footprint

SORIN GROUP ITALIA S.R.L. - CRM FACILITY accounts for 5,092 FDA MAUDE reports (#368 of 434, thin-book tercile). Death-coded event_type share is 1.00% (elevated); Injury share 29.1% (balanced).

What the volume reading shows for SORIN GROUP ITALIA S.R.L. - CRM FACILITY

The standout signal for SORIN GROUP ITALIA S.R.L. - CRM FACILITY is filing volume: 5,092 adverse-event reports in FDA MAUDE (#368 of 434, thin-book). Death-coded event_type share sits at 1.00% (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 20 device types, led in this extract by Malfunction at 3,559 (69.9% of event_type total). Peak single-year volume reaches 976 reports across 13 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

5,092
Total Reports
51
Event-type Death
1,482
Injury Reports
20
Device Types

Event Types

Malfunction 3,559 (69.9%)
Injury 1,482 (29.1%)
Death 51 (1.0%)

Patient Outcomes

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

3,337 (63.2%)
Required Intervention 1,389 (26.3%)
Hospitalization 237 (4.5%)
R 183 (3.5%)
Death 88 (1.7%)
Other 23 (0.4%)
Life Threatening 14 (0.3%)
H 3 (0.1%)
L 3 (0.1%)
Congenital Anomaly 3 (0.1%)
O 2 (0.0%)
S 1 (0.0%)

Devices (20)

Device Reports
Defibrillator, Implantable, Dual-Chamber 1,243
Pulse Generator, Permanent, Implantable 1,129
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) 670
Programmer, Pacemaker 554
Implantable Pulse Generator, Pacemaker (Non-Crt) 523
Permanent Pacemaker Electrode 394
Pacemaker/Icd/Crt Non-Implanted Components 206
Implantable Pacemaker Pulse-Generator 187
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes 71
Implantable Cardioverter Defibrillator (Non-Crt) 63
Permanent Defibrillator Electrodes 24
Electrocardiograph, Ambulatory (Without Analysis) 9
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) 5
Cable, Transducer And Electrode, Patient, (Including Connector) 1
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 1
Computer, Diagnostic, Programmable 1
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode 1
Glucose Dehydrogenase, Glucose 1
Phosphomolybdate (Colorimetric), Inorganic Phosphorus 1
Pulse-Generator, Single Chamber, Sensor Driven, Implantable 1

Yearly Trend

14
2014: 541
15
2015: 701
16
2016: 783
17
2017: 834
18
2018: 976
19
2019: 616
20
2020: 352
21
2021: 106
22
2022: 91
23
2023: 43
24
2024: 16
25
2025: 22
26
2026: 11

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