PlainHospital

BOSTON SCIENTIFIC - SPENCER

Manufacturer adverse-event records for BOSTON SCIENTIFIC - SPENCER 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 · 2006–2018 · mid-book · typical Death-code · balanced

Death-code intensity

BOSTON SCIENTIFIC - SPENCER tracks a typical Death-code share

Death-coded event_type rows are 51 of 11,000 (0.46% · typical tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for BOSTON SCIENTIFIC - SPENCER

The standout signal for BOSTON SCIENTIFIC - SPENCER is Death-code intensity: 0.46% of 11,000 reports (typical tercile), while absolute volume is mid-book.

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

Reports span 20 device types, led in this extract by Malfunction at 8,007 (72.8% of event_type total). Peak single-year volume reaches 1,649 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

11,000
Total Reports
51
Event-type Death
2,938
Injury Reports
20
Device Types

Event Types

Malfunction 8,007 (72.8%)
Injury 2,938 (26.7%)
Death 51 (0.5%)
4 (0.0%)

Patient Outcomes

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

8,048 (72.3%)
Other 1,621 (14.6%)
Required Intervention 1,054 (9.5%)
Hospitalization 223 (2.0%)
R 108 (1.0%)
Death 54 (0.5%)
O 21 (0.2%)
H 2 (0.0%)

Devices (20)

Device Reports
Tubes, Gastrointestinal (And Accessories) 1,781
Stents, Drains And Dilators For The Biliary Ducts 1,344
Ligator, Hemorrhoidal 1,047
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) 972
Lithotriptor, Biliary Mechanical 712
Choledochoscope And Accessories, Flexible/Rigid 692
Dislodger, Stone, Basket, Ureteral, Metal 557
Mesh, Surgical, Polymeric 467
Ligator, Esophageal 455
Electrosurgical, Cutting & Coagulation & Accessories 402
Endoscopic Cytology Brush 313
Fastener, Fixation, Nondegradable, Soft Tissue 289
Biopsy Needle 273
Bronchoscope (Flexible Or Rigid) 230
Tube, Gastro-Enterostomy 162
Device, Thermal Ablation, Endometrial 146
Snare, Flexible 117
Dislodger, Stone, Biliary 116
Introducer, Catheter 100
Tube, Drainage, Suprapubic 82

Yearly Trend

06
2006: 2
08
2008: 1
09
2009: 18
10
2010: 1,649
11
2011: 1,507
12
2012: 1,361
13
2013: 1,354
14
2014: 1,021
15
2015: 1,200
16
2016: 1,084
17
2017: 915
18
2018: 888

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