Medtronic Puerto Rico, Inc.
FDA adverse event reports naming Medtronic Puerto Rico, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC PUERTO RICO, INC..
- Total reports
- 69,774
- Deaths
- 8,204
- Injuries
- 40,559
- Malfunctions
- 20,798
Reports per year
62098
19599
58800
64501
60702
59903
49204
91005
1,65406
3,17107
4,10208
4,53209
14,68010
19,07311
17,07612
Source: FDA adverse event reports by year received, 1998–2012. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Permanent Pacemaker ElectrodeDTB38,538
- Implantable Cardioverter Defibrillator (Non-Crt)LWS24,244
- Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX2,964
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN2,603
- Implantable Pacemaker Pulse-GeneratorDXY571
- Permanent Defibrillator ElectrodesNVY359
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP338
- Catheter, PercutaneousDQY71
- Cardiac Ablation Percutaneous CatheterLPB15
- Pulse Generator, Permanent, ImplantableNVZ15
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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