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Early fatigue fractures in the IS-1 connector leg of a small-diameter ICD lead: Value of returned product analysis for improving device safety |
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| Authors: | Robert G. Hauser Linda M. Kallinen Retel BS FHRS |
| Affiliation: | Patient Safety and Advocacy Center, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota |
| Abstract: | |
| Keywords: | FDA, Food and Drug Administration ICD, implantable cardioverter-defibrillator MAUDE, Manufacturers and User Facility Device Experience PPR, product performance report RPA, returned product analysis SJM, St Jude Medical |
| 本文献已被 ScienceDirect 等数据库收录！ | |