Table 1. Characteristics of the 290 141 Reports in Which the Natural Language Processing Algorithm Identified a Serious Injury or Death.
| Characteristic | No. (%) |
|---|---|
| Report type | |
| Death | 151 145 (52.1) |
| Injury | 77 516 (26.7) |
| Malfunction | 58 025 (20.0) |
| Other/missing | 3455 (1.2) |
| Device class | |
| I | 7399 (2.6) |
| II | 116 358 (40.1) |
| III | 162 147 (55.9) |
| Undetermined | 4237 (1.5) |
| Year of report receipt by FDA | |
| Before 1995 | 1161 (0.4) |
| 1995-1999 | 11 467 (4.0) |
| 2000-2004 | 13 198 (4.5) |
| 2005-2009 | 24 675 (8.5) |
| 2010-2014 | 94 170 (32.5) |
| 2015-April 2020 | 145 377 (50.1) |
| Missing | 93 (0.0) |
| Report source | |
| Manufacturer | 278 251 (95.9) |
| User facility | 6172 (2.1) |
| Voluntary | 4778 (1.6) |
| Distributor | 940 (0.3) |
| Reporter occupation | |
| Unspecifieda | 139 436 (48.1) |
| Physician | 58 787 (20.3) |
| Health care personnelb | 41 329 (14.2) |
| Attorney | 26 314 (9.1) |
| Nurse | 10 965 (3.8) |
| Patient, patient family, or caregiver | 6757 (2.3) |
| Risk manager | 4792 (1.7) |
| Medical equipment company technician/representative | 1538 (0.5) |
| Service/testing personnel | 223 (0.1) |
| Device product codec | |
| DSQ: ventricular (assist) bypass | 38 708 (13.3) |
| KPO: dialysate concentrate for hemodialysis (liquid or powder) | 25 261 (8.7) |
| HHS: transcervical contraceptive tubal occlusion device | 14 387 (5.0) |
| NIQ: coronary drug-eluting stent | 11 296 (3.9) |
| LWS: implantable cardioverter-defibrillator (non-CRT) | 10 006 (3.4) |
| MVK: wearable automated external defibrillator | 9273 (3.2) |
| DTB: permanent pacemaker electrode | 8332 (2.9) |
| MIH: system, endovascular graft, aortic aneurysm treatment | 6562 (2.3) |
| DTK: filter, intravascular, cardiovascular | 5777 (2.0) |
| LZG: pump, infusion, insulin | 5005 (1.7) |
Abbreviations: CRT, cardiac resynchronization therapy; FDA, US Food and Drug Administration.
a
Includes no information, not applicable, other, and unknown.
b
Includes audiologist, biomedical engineer, dental assistant, dental hygienist, dentist, dietician, emergency medical technician, health professional, home health aide, hospital service technician, medical assistant, medical technologist, nuclear medicine technologist, nursing assistant, occupational therapist, other health care professional, paramedic, personal care assistant, pharmacist, phlebotomist, physical therapist, physician assistant, physicist, radiology technologist, and respiratory therapist.
c
Includes only the top 10 most frequently represented product codes.