title: [Discrepancy between clinical data and approval documents].
abstract: Pacemakers, ICDs and stents are now playing a major role in cardiology. Again and again, however, there are reports of malfunctions and related deaths. Researchers have now compared the study results of cardiac high-risk products in the registration documents of the US Food and Drug Administration with peer-reviewed publications.
authors: Klinik und Poliklinik für Herzchirurgie, Universitätsklinikum Bonn.
authors: Fritz
authors: F
authors: Mellert
authors: Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn.
authors: Jan-Malte
authors: JM
authors: Sinning
mesh_terms: D002309:Cardiology / Q000295:instrumentation*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000706:statistics & numerical data; D018795:Device Approval; D004282:Documentation / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D062527:Meaningful Use / Q000706:statistics & numerical data; D010138:Pacemaker, Artificial / Q000009:adverse effects / Q000706:statistics & numerical data; D019736:Prostheses and Implants / Q000009:adverse effects / Q000706:statistics & numerical data*; D015607:Stents / Q000009:adverse effects / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration