GUIDANT CRM CLONMEL IRELAND

Manufacturer adverse-event records for GUIDANT CRM CLONMEL IRELAND 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 · 2003–2018 · heavy-book · elevated Death-code · injury-heavy

Volume signature

GUIDANT CRM CLONMEL IRELAND sits in the heavy MAUDE book

GUIDANT CRM CLONMEL IRELAND accounts for 79,199 FDA MAUDE reports (#40 of 443, heavy-book tercile). Death-coded event_type share is 1.07% (elevated); Injury share 55.1% (injury-heavy).

What the volume reading shows for GUIDANT CRM CLONMEL IRELAND

The standout signal for GUIDANT CRM CLONMEL IRELAND is filing volume: 79,199 adverse-event reports in FDA MAUDE (#40 of 443, heavy-book). Death-coded event_type share sits at 1.07% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair GUIDANT CRM CLONMEL IRELAND with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 19 device types, led in this extract by Injury at 43,609 (55.1% of event_type total). Peak single-year volume reaches 10,045 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

79,199
Total Reports
851
Event-type Death
43,609
Injury Reports
19
Device Types

Event Types

Injury 43,609 (55.1%)
Malfunction 34,711 (43.8%)
Death 851 (1.1%)
Other 23 (0.0%)
5 (0.0%)

Patient Outcomes

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

34,597 (25.2%)
R 30,599 (22.2%)
Hospitalization 29,507 (21.5%)
L 29,069 (21.1%)
Required Intervention 5,479 (4.0%)
Life Threatening 3,745 (2.7%)
Other 2,884 (2.1%)
Death 878 (0.6%)
O 491 (0.4%)
H 254 (0.2%)
Congenital Anomaly 32 (0.0%)
S 16 (0.0%)
Disability 5 (0.0%)
D 1 (0.0%)

Yearly Trend

03
2003: 1
04
2004: 9
05
2005: 33
06
2006: 96
07
2007: 149
08
2008: 289
09
2009: 9,170
10
2010: 8,701
11
2011: 7,762
12
2012: 4,928
13
2013: 5,567
14
2014: 7,476
15
2015: 6,855
16
2016: 8,915
17
2017: 9,203
18
2018: 10,045